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The use of transcatheter aortic valve implantation (TAVI) is evolving. Our Cardiovascular Evaluation Unit is implementing a comprehensive approach to inform decision-makers on optimal use of TAVI, including the development of quality standards. We are implementing a multifaceted evaluation framework in collaboration with clinical stakeholders.
Our unit has carried out a continuous field evaluation in collaboration with the clinical teams at all six TAVI centers in Québec for the past four years (1 April 2013–31 March 2017), with regular feedback to the teams and sharing of results with each individual center. Hospital documentation was reviewed according to established national quality indicator definitions. Field evaluation data were combined with the results of systematic literature review to establish provincial standards for practice, through a deliberation process by an interdisciplinary committee of clinical experts from each center. Systematic surveillance of the literature is ongoing.
In the period 2013–2017, use of TAVI in Québec was limited to very elderly patients with significant comorbidities at high risk of operative mortality. We observed improvements in both processes of care (e.g. documentation of risk scores) and clinical outcomes (e.g. 30-day and 1-year mortality) over time. Our consensus standards recognize the potential value of TAVI for patients at moderate operative risk, identify uncertainties and recommend best practices for patient evaluation and clinical decision-making about choice of treatment.
A comprehensive, long-term evaluation process of TAVI with feedback to centers is associated with improvements in processes of care and outcomes. In the present context of expanding clinical indications, we will continue to evaluate patient selection, processes and outcomes according to the newly-established provincial quality standards. This iterative approach facilitates continued evidence generation and decision-making for optimal use of an evolving intervention. We acknowledge the contribution of the members of the expert clinical committee.
One important objective at the Institut d'excellence en santé et en services sociaux (INESSS) is to guide the implementation of promising new technologies into Québec's healthcare system. A comprehensive evaluation framework was recently developed that takes into account the dynamic and iterative nature of the life cycle of such technologies. This framework is presently being used to inform the decision-making process concerning use of thrombectomy for ischemic stroke.
A field evaluation has been undertaken since April 2016 in all four of Québec's specialized tertiary stroke centers. This real-world evidence is communicated regularly to the clinical teams as well as decision-makers. A systematic literature surveillance is also ongoing, with results being shared amongst clinical experts on our interdisciplinary advisory committee. On the basis of the generated evidence from these sources, recommendations to optimize structures, processes of care and clinical outcomes will be developed, in collaboration with the interdisciplinary committee.
Thrombectomy has been shown to be safe and effective for treating ischemic stroke in the randomized trial setting in high-volume, expert centers. Real-world evidence from Québec indicates increasing use of this new technology but with wide variation across health regions. Observed times to treatment appear favorable for patients admitted directly to tertiary centers, but inter-hospital transfer is associated with important increases in delays from first door to thrombectomy. The documentation of 90-day outcomes is problematic, especially for patients transferred out of tertiary stroke centers prior to discharge. Uncertainties raised in the literature include patient selection criteria and optimal processes of care during prehospital and inter-hospital phases of the patient's trajectory.
The ongoing comprehensive evaluation of thrombectomy for ischemic stroke in Québec is a concrete example of how the use of an innovative, disruptive technology can be optimized. We acknowledge the contribution of the members of the clinical expert committee.
Decision-making about replacement or modification of an implantable cardioverter defibrillator (ICD) must be patient-centered and clinically appropriate. We engaged both patients and health care professionals in a multi-method approach in order to recommend structures and processes that facilitate informed and shared decision-making.
A systematic literature review (2000 to 2017) was performed focusing on the patient's perspective and the optimal organization of structures and processes for decision-making. A province-wide field evaluation based on medical chart review was carried out to provide ‘real world’ evidence in Québec's six ICD implanting centers (1 July to 31 December, 2016; N = 418). Patients and health care professionals reviewed the findings of the review and field evaluation, and deliberated recommendations in an anonymous manner by electronic mail. A joint meeting focused on proposed recommendations concerning shared decision-making.
The patients provided feedback on the literature review based on their ICD experience, and highlighted the need for better and more interactive decision aids, clinical information and time, and a private space for sensitive discussions. The field evaluation underlined the variability of treatment choices at the time of replacement and that more than one in ten patients had undergone ICD deactivation. Proposed recommendations focus on multi-disciplinary, integrated follow-up of patients and outline best practice for incorporating patient wishes and life objectives when discussing treatment options. The multi-round consultation process allowed both patients and professionals to co-construct recommendations with our evaluation team.
This multi-method approach enriched our interpretation of literature and ‘real world’ data and facilitated identification and prioritization of important themes. Partnership with both patients and clinicians added a new and energizing dynamic to our evaluation and recommendation processes. We acknowledge the contribution of the members of the patient committee and the clinical experts committee.
Our cardiovascular evaluation unit is mandated to evaluate transcatheter aortic valve implantation (TAVI) in the province of Québec. In 2012, it was recommended that only patients at too high risk for surgery receive TAVI. In partnership with our six hospital TAVI programs, we have measured indicators of structure, process and outcomes since 2013. We are collaborating with multidisciplinary clinical experts to update recommendations for optimal use. Herein, we present the evolving portrait of TAVI in Québec and identify priority issues.
Clinical data were collected and analyzed for all TAVI performed from 1 April 2013 to 31 March 2016. Regular site feedback was provided. A systematic review of recent guidelines and randomized trials facilitated the interpretation of “real world” results and formulation of provincial quality standards.
Provincial TAVI volume increased from 294 in 2013–14 to 340 in 2014–15, and to 360 in 2015–16. Patient age and sex distribution remained relatively constant over time (median age 83 years; 47 percent female). However, the median predicted risk of operative mortality (STS score) decreased in the latest period [6 percent (Interquartile Range, IQR: 4–9) versus 7 percent (IQR: 4–9) versus 4 percent (IQR: 3–7)], suggesting TAVI is increasingly being performed in lower-risk patients. Clinical documentation and processes of care generally improved. Thirty-day mortality decreased (6.1 percent versus 4.1 percent versus 2.8 percent). The literature review identified two central issues: TAVI futility in patients who are too sick and apparent non-inferiority of TAVI compared with surgical valve replacement in medium-risk patients.
Our province-wide TAVI evaluation indicates improving processes and outcomes. Patient selection remains the key in our universal healthcare system, with the need to minimize futile and costly therapy and offer TAVI to those most likely to benefit. Continued monitoring of clinical practice and newly-established quality standards, in close collaboration with clinical teams, remains essential to promote optimal use of this evolving technology.
In the past decade numerous efforts have been made to enhance quality of care in the province of Québec for patients with ST-elevation myocardial infarction (STEMI). Despite two prior field evaluations and diffusion of a systematic review as well as recommendations, a third audit revealed persistent gaps in care, specifically excessive treatment delays. Our cardiovascular evaluation unit thus aimed to develop a more comprehensive quality improvement framework that further engaged healthcare professionals.
A literature update identified best practices and ways to reduce treatment delays and improve outcomes. This review, combined with the latest evaluation results, was used to establish structural and process quality standards adapted to the Québec context, via a consensus process with a panel of clinical experts. The standards identified quality-of-care targets and key elements of a governance structure to guide the improvement process. Quality indicators to monitor change were also developed. An implementation plan was then created, likewise based on literature and evaluation results.
For the first time, the unit publicly disseminated the results of the third evaluation according to region, in addition to standard individual hospital “report cards”. A summit conference was held during which the standards and indicators were presented to clinicians and other stakeholders, in collaboration with the health ministry and a panel of cardiovascular experts. Site visits are planned to facilitate change and establishment of local improvement plans and committees. A “tool kit” was developed containing a treatment algorithm, a drug protocol, five quality indicators each for processes and care networks, and measurement tools for indicators. A 75 percent minimal achievement target was set for treatment times.
A comprehensive framework aimed at improving quality of care for STEMI patients and monitoring change was created by combining evidence from the literature and “real world” data and mobilizing key stakeholders.
Computerized interpretation of the prehospital electrocardiogram (ECG) is increasingly being used in the basic life support (BLS) ambulance setting to reduce delays to treatment for patients suspected of ST segment elevation myocardial infarction (STEMI).
To estimate 1) predictive values of computerized prehospital 12-lead ECG interpretation for STEMI and 2) additional on-scene time for 12-lead ECG acquisition.
Over a 2-year period, 1,247 ECGs acquired by primary care paramedics for suspected STEMI were collected. ECGs were interpreted in real time by the GEMarquette 12SL ECG analysis program. Predictive values were estimated with a bayesian latent class model incorporating the computerized ECG interpretations, consensus ECG interpretations by study cardiologists, and hospital diagnosis. On-scene time was compared for ambulance-transported patients with (n 5 985) and without (n 5 5,056) prehospital ECGs who received prehospital aspirin and/or nitroglycerin.
The computer's positive and negative predictive values for STEMI were 74.0% (95% credible interval [CrI] 69.6–75.6) and 98.1% (95% CrI 97.8–98.4), respectively. The sensitivity and specificity were 69.2% (95% CrI 59.0–78.5) and 98.9% (95% CrI 98.1–99.4), respectively. Prehospital ECGs were associated with a mean increase in on-scene time of 5.9 minutes (95% confidence interval 5.5–6.3).
The predictive values of the computerized prehospital ECG interpretation appear to be adequate for diversion programs that direct patients with a positive result to hospitals with angioplasty facilities. The estimated 26.0% chance that a positive interpretation is false is likely too high for activation of a catheterization laboratory from the field. Acquiring prehospital ECGs does not substantially increase on-scene time in the BLS setting.
Timely reperfusion therapy for ST-elevation myocardial infarction (STEMI) is an important determinant of outcome, yet targets for time to treatment are frequently unmet in North America. Prehospital strategies can reduce time to reperfusion. We sought to determine the extent to which emergency medical services (EMS) use these strategies in Canada.
We carried out a cross-sectional survey in 2007 of ground EMS operators in British Columbia, Alberta, Ontario, Quebec and Nova Scotia. We focused on the use of 4 prehospital strategies: 1) 12-lead electrocardiogram (ECG), 2) routine expedited emergency department (ED) transfer of STEMI patients (from a referring ED to a percutaneous coronary intervention [PCI] centre), 3) prehospital bypass (ambulance bypass of local EDs to transport patients directly to PCI centres) and 4) prehospital fibrinolysis.
Ninety-seven ambulance operators were surveyed, representing 15 681 paramedics serving 97% of the combined provincial populations. Of the operators surveyed, 68% (95% confidence interval [CI] 59%–77%) had ambulances equipped with 12-lead ECGs, ranging from 40% in Quebec to 100% in Alberta and Nova Scotia. Overall, 47% (95% CI 46%-48%) of paramedics were trained in ECG acquisition and 40% (95% CI 39%–41%) were trained in ECG interpretation. Only 18% (95% CI 10%–25%) of operators had prehospital bypass protocols; 45% (95% CI 35%–55%) had protocols for expedited ED transfer. Prehospital fibrinolysis was available only in Alberta. All EMS operators in British Columbia, Alberta and Nova Scotia used at least 1 of the 4 prehospital strategies, and one-third of operators in Ontario and Quebec used 0 of 4. In major urban centres, at least 1 of the 3 prehospital strategies 12-lead ECG acquisition, bypass or expedited transfer was used, but there was considerable variation within and across provinces.
The implementation of widely recommended prehospital STEMI strategies varies substantially across the 5 provinces studied, and relatively simple existing technologies, such as prehospital ECGs, are underused in many regions. Substantial improvements in prehospital services and better integration with hospital-based care will be necessary in many regions of Canada if optimal times to reperfusion, and associated outcomes, are to be achieved.
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