Use of the ClearSight® System for Continuous Noninvasive Hemodynamic Monitoring during Heart Valve Interventions: Review of the Literature and Single-Site Experience

  • George Gellert Interventional Echocardiography, Structural Heart Program, Banner - University Medical Center Phoenix, Phoenix, AZ, USA
  • Peter Bramlage Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany

Abstract

During interventional and structural cardiology procedures, such as mitral valve (MitraClip, BMV), aortic valve (TAVR, BAV), tricuspid valve (MitraClip), left atrial appendage (Watchman, Lariat), atrial septum (ASD/PFO closure), and coronary artery intervention (high-risk PCI), among others, patients are at a high risk of hemodynamic instability and require continuous monitoring. This is conventionally achieved through arterial catheterization and transpulmonary thermodilution. However, such invasive techniques are time-consuming and have been associated with steep learning curves, vascular complications, and increased risk of infection. In line with the ongoing simplification and improvement of the catheter-based valve intervention, it is logical to investigate the effectiveness of continuous noninvasive hemodynamic monitoring in this setting. Over the last
2 years, our team has performed over 400 valve procedures with continuous hemodynamic monitoring via the noninvasive ClearSight system. This system is based on a finger-cuff and automated volume-clamp technology integrated into a simplified clinical platform (EV1000 NI). Although current evidence suggests that the technology results in slight differences in arterial pressure (AP) and cardiac output (CO) relative to the current, commercially available, invasive approaches, we have found the bias to be acceptable. Both the noninvasive and the invasive approaches have the same percentage of error when compared to the true CO and provide beat-by-beat detection of acute changes facilitating shorter response times. In addition to AP and CO, the system provides up-to-date information on stroke volume (SV), stroke volume variation (SVV), and systemic vascular resistance, which can be useful in aiding decision-making and provide better postoperative outcomes, such as shorter length of stay (LOS), decreased postoperative infection, decreased postoperative arrhythmia, decreased postoperative renal failure, decreased postoperative congestive heart failure (CHF), and decreased readmission. Additionally, the simplicity of the system setup has translated into a time saving of up to 3 hours per day, allowing one team to perform an additional 2 to 3 valve interventions without moving rooms. Moving forward, a formal study comparing patient outcomes and cost-effectiveness between invasive and noninvasive hemodynamic monitoring techniques in valve replacement would be insightful.

References

Alfano G, Fontana F, Cappelli G. 2017. Noninvasive blood pressure measurement in maintenance hemodialysis patients: comparison of agreement between oscillometric and finger-cuff methods. Nephron 136: 309-17.

Ameloot K, Van De Vijver K, Broch O, et al. 2013. Nexfin noninvasive continuous hemodynamic monitoring: validation against continuous pulse contour and intermittent transpulmonary thermodilution derived cardiac output in critically ill patients. ScientificWorldJournal 2013:519080.

Ameloot K, Van De Vijver K, Van Regenmortel N, et al. 2014. Validation study of Nexfin® continuous non-invasive blood pressure monitoring in critically ill adult patients. Minerva Anestesiol 80:1294-301.

Balzer F, Habicher M, Sander M, et al. 2016. Comparison of the non-invasive Nexfin® monitor with conventional methods for the measurement of arterial blood pressure in moderate risk orthopaedic surgery patients. J Int Med Res 44:832-43.

Belda FJ, Aguilar G, Teboul JL, et al. 2011. Complications related to less-invasive haemodynamic monitoring. Br J Anaesth 106:482-6.

Berg K, Riesenberg LA, Berg D, et al. 2014. The development of a validated checklist for radial arterial line placement: preliminary results. Am J Med Qual 29:242-6.

Berkelmans GFN, Kuipers S, Westerhof BE, Spoelstra-de Man AME, Smulders YM. 2018. Comparing volume-clamp method and intra-arterial blood pressure measurements in patients with atrial fibrillation admitted to the intensive or medium care unit. J Clin Monit Comput 32:439-46.

Bland JM, Altman DG. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1:307-10.

Bogert LW, Wesseling KH, Schraa O, et al. 2010. Pulse contour cardiac output derived from non-invasive arterial pressure in cardiovascular disease. Anaesthesia 65:1119-25.

Broch O, Bein B, Gruenewald M, et al. 2013. A comparison of continuous non-invasive arterial pressure with invasive radial and femoral pressure in patients undergoing cardiac surgery. Minerva Anestesiol 79:248-56.

Broch O, Renner J, Gruenewald M, et al. 2012. A comparison of the Nexfin® and transcardiopulmonary thermodilution to estimate cardiac output during coronary artery surgery. Anaesthesia 67:377-83.

Bubenek-Turconi SI, Craciun M, Miclea I, Perel A. 2013. Noninvasive continuous cardiac output by the Nexfin before and after preload-modifying maneuvers: a comparison with intermittent thermodilution cardiac output. Anesth Analg 117:366-72.

Cattaneo S, Lagrotta M. 2010. Transcatheter implantation of an aortic valve: anesthesiological management. Minerva Anestesiol 76:287-9.

ClearSight System Setup Guide. c2013. Irvine (CA): Edwards Lifesciences; [accessed 2018 Aug 22]. http://ht.edwards.com/scin/edwards/sitecollectionimages/products/mininvasive/ar10425-clearsight_setupguide_4x6_us_1hrcrop.pdf.

de Wilde RB, de Wit F, Geerts BF, et al. 2016. Non-invasive continuous arterial pressure and pulse pressure variation measured with Nexfin® in patients following major upper abdominal surgery: a comparative study. Anaesthesia 71:788-97.

Dolmatova E, Moazzami K, Cocke TP, et al. 2017. Extracorporeal membrane oxygenation in transcatheter aortic valve replacement. Asian Cardiovasc Thorac Ann 25:31-4.

Falcao-Pires I, Hamdani N, Borbely A, et al. 2011. Diabetes mellitus worsens diastolic left ventricular dysfunction in aortic stenosis through altered myocardial structure and cardiomyocyte stiffness. Circulation 124:1151-9.

Fassl J, Walther T, Groesdonk HV, et al. 2009. Anesthesia management for transapical transcatheter aortic valve implantation: a case series. J Cardiothorac Vasc Anesth 23:286-91.

Fischer MO, Avram R, Cârjaliu I, et al. 2012. Non-invasive continuous arterial pressure and cardiac index monitoring with Nexfin after cardiac surgery. Br J Anaesth 109:514-21.

Giustino G, Montorfano M, Chieffo A, et al. 2014. TCT-776 Risk factors and clinical significance of intra-procedural haemodynamic instability in patients undergoing transcatheter aortic valve implantation. JACC 64(11 suppl):B227.

Heusdens JF, Lof S, Pennekamp CW, et al. 2016. Validation of non-invasive arterial pressure monitoring during carotid endarterectomy. Br J Anaesth 117:316-23.

Hofhuizen C, Lansdorp B, van der Hoeven JG, Scheffer GJ, Lemson J. 2014. Validation of noninvasive pulse contour cardiac output using finger arterial pressure in cardiac surgery patients requiring fluid therapy. J Crit Care 29:161-5.

Hohn A, Defosse JM, Becker S, Steffen C, Wappler F, Sakka SG. 2013. Non-invasive continuous arterial pressure monitoring with Nexfin does not sufficiently replace invasive measurements in critically ill patients. Br J Anaesth 111:178-84.

Joosten A, Desebbe O, Suehiro K, et al. 2017. Accuracy and precision of non-invasive cardiac output monitoring devices in perioperative medicine: a systematic review and meta-analysis. Br J Anaesth 118:298-310.

Kalmar AF, Vos JJ, Weening M, et al. 2012. Validation of continuous noninvasive arterial blood pressure measurements during general anesthesia. Presented at: ANESTHESIOLOGY™ 2012 Annual Meeting; Washington, DC. Abstract 174.

Kalmar AF, Wesseling W, Scheeren TWL. 2013. Technology report: ccNexfin monitor. Nederlands Tijdschrift voor Anesthesiologie 26:3-7.

Konrad C, Schupfer G, Wietlisbach M, Gerber H. 1998. Learning manual skills in anesthesiology: is there a recommended number of cases for anesthetic procedures? Anesth Analg 86:635-9.

Kuster M, Exadaktylos A, Schnuriger B. 2015. Non-invasive hemodynamic monitoring in trauma patients. World J Emerg Surg 10:11.

Landes U, Barsheshet A, Finkelstein A, et al. 2017. Temporal trends in transcatheter aortic valve implantation, 2008-2014: patient characteristics, procedural issues, and clinical outcome. Clin Cardiol 40:82-8.

Lee C, Casserly I, Fahy E. 2017. 43 Comparing outcomes in patients undergoing tavi: general anaesthetic versus conscious sedation. Heart 103:A25-6.

Lorente L, Santacreu R, Martín MM, Jiménez A, Mora ML. 2006. Arterial catheter-related infection of 2,949 catheters. Crit Care 10:R83.

Maass SW, Roekaerts PM, Lance MD. 2014. Cardiac output measurement by bioimpedance and noninvasive pulse contour analysis compared with the continuous pulmonary artery thermodilution technique. J Cardiothorac Vasc Anesth 28:534-9.

Maggi R, Viscardi V, Furukawa T, Brignole M. 2010. Non-invasive continuous blood pressure monitoring of tachycardic episodes during interventional electrophysiology. Europace 12:1616-22.

Malbrain MLNG, De Potter TJR, Deeren D. 2005. Cost-effectiveness of minimally invasive hemodynamic monitoring. In: Vincent JL, editor. Yearbook of intensive care and emergency medicine. New York (NY): Springer. p 603-31.

Martina JR, Westerhof BE, Van Goudoever J, et al. 2010. Noninvasive blood pressure measurement by the Nexfin monitor during reduced arterial pulsatility: a feasibility study. ASAIO J 56:221-7.

Martina JR, Westerhof BE, van Goudoever J, et al. 2012. Noninvasive continuous arterial blood pressure monitoring with Nexfin®. Anesthesiology 116:1092-103.

Mayr NP, Michel J, Bleiziffer S, Tassani P, Martin K. 2015. Sedation or general anesthesia for transcatheter aortic valve implantation (TAVI). J Thorac Dis 7:1518-26.

Moist LM, Lok CE, Vachharajani TJ, et al. 2012. Optimal hemodialysis vascular access in the elderly patient. Semin Dial 25:640-8.

Monnet X, Picard F, Lidzborski E, et al. 2012. The estimation of cardiac output by the Nexfin device is of poor reliability for tracking the effects of a fluid challenge. Crit Care 16:R212.

Nuttall G, Burckhardt J, Hadley A, et al. 2016. Surgical and patient risk factors for severe arterial line complications in adults. Anesthesiology 124:590-7.

O’Brien E, Atkins N, Stergiou G, et al. 2010. European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit 15:23-38.

Osnabrugge RLJ, Mylotte D, Head SJ, et al. 2013. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol 62:1002-12.

Peter L, Noury N, Cerny M. 2014. A review of methods for non-invasive and continuous blood pressure monitoring: pulse transit time method is promising? IRBM 35:271-82.

Petzoldt M, Riedel C, Braeunig J, et al. 2015. Dynamic device properties of pulse contour cardiac output during transcatheter aortic valve implantation. J Clin Monit Comput 29:323-31.

Raggi EP, Sakai T. 2017. Update on finger-application-type noninvasive continuous hemodynamic monitors (CNAP and ccNexfin): physical principles, validation, and clinical use. Semin Cardiothorac Vasc Anesth 21:321-9.

Safdar N, O’Horo JC, Maki DG. 2013. Arterial catheter-related bloodstream infection: incidence, pathogenesis, risk factors and prevention. J Hosp Infect 85:189-95.

Scheer BV, Perel A, Pfeiffer UJ. 2002. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care 6:199-204.

Schraverus P, Kuijpers MM, Coumou J, Boly CA, Boer C, van Kralingen S. 2016. Level of agreement between cardiac output measurements using Nexfin® and thermodilution in morbidly obese patients undergoing laparoscopic surgery. Anaesthesia 71:1449-55.

Siddiqui F, Strus J, Ming X, Lee IA, Chokroverty S, Walters AS. 2007. Rise of blood pressure with periodic limb movements in sleep and wakefulness. Clin Neurophysiol 118:1923-30.

Sperna Weiland NH, de Wever JW, van Duivenvoorde Y, et al. 2018. Agreement between ccNexfin CO-trek cardiac output and intermittent cold-bolus pulmonary thermodilution in a prospective multicenter study. Minerva Anestesiol 84:473-80.

Stelfox HT, Ahmed SB, Ribeiro RA, Gettings EM, Pomerantsev E, Schmidt U. 2006. Hemodynamic monitoring in obese patients: the impact of body mass index on cardiac output and stroke volume. Crit Care Med 34:1243-6.

Stenglova A, Benes J. 2017. Continuous non-invasive arterial pressure assessment during surgery to improve outcome. Front Med (Lausanne) 4:202.

Stover JF, Stocker R, Lenherr R, et al. 2009. Noninvasive cardiac output and blood pressure monitoring cannot replace an invasive monitoring system in critically ill patients. BMC Anesthesiol 9:6.

Tamburino C, Capodanno D, Ramondo A, et al. 2011. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 123:299-308.

Van de Vijver K, Verstraeten A, Gillebert C, et al. 2011. Validation of non-invasive hemodynamic monitoring with Nexfin in critically ill patients. Crit Care 15(suppl 1):P75.

Vos JJ, Poterman M, Mooyaart EA, et al. 2014. Comparison of continuous non-invasive finger arterial pressure monitoring with conventional intermittent automated arm arterial pressure measurement in patients under general anaesthesia. Br J Anaesth 113:67-74.

Weiss E, Gayat E, Dumans-Nizard V, Le Guen M, Fischler M. 2014. Use of the Nexfin device to detect acute arterial pressure variations during anaesthesia induction. Br J Anaesth 113:52-60.

Published
2018-11-14
Section
Articles