Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) CoreValve ReValving System: results from the multicentre, expanded evaluation registry 1-year following CE mark approval

Piazza, Nicolò; Grube, Eberhard; Gerckens, Ulrich; Heijer, Peter den; Linke, Axel; Luha, Olev; Ramondo, Angelo; Ussia, Giampaolo; Wenaweser, Peter; Windecker, Stephan; Laborde, Jean‐Claude; Jaegere, Peter de; Serruys, Patrick W.

doi:10.4244/eijv4i2a43

Cited by 589 publications

(376 citation statements)

References 23 publications

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“…(9,10,12,18) At 3 -15 months follow-up, mortality rates were also comparable to other studies. (12,13,15,16) Our experience regarding short term mortality for valve-in-valve TAVI differs from other data. (23,24) In 47 patients reported by Webb, et al…”

Section: Discussionsupporting

confidence: 74%

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Transcutanous aortic valve replacement with Medtronic CoreValve in a publicprivate partnership hospital complex

Theron¹,

Brown²,

Smit³

et al. 2017

SAHJ

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526Transcutanous aortic valve replacement with Medtronic CoreValve in a publicprivate partnership hospital complex both death and hospitalisation. Reported 30 day mortality ranges from 5 -15% (9-13) with 1 year survival ranging from 60 -80%. (8,10,(14)(15)(16) Improvement in symptomatology and valvular hemodynamic were also sustained at 2 years of follow-up. (10,13,16) The long-term durability of TAVI valves still has to be ascertained, but the 3 -5 year results are promising. (15 INTRODUCTIONIn the developed world, aortic stenosis (AS) is the most frequent type of valvular heart lesion found in the elderly. It primarily presents as calcific aortic stenosis in adults of advanced age above 65 years. (1,2) In asymptomatic individuals with severe AS, average event-free survival at 2 years ranges from 20 -50%. However, in symptomatic patients the prognosis is dismal with survival rates of 15 -50% at 5 years. (3)(4)(5) Aortic valve replacement is the definitive therapy for severe AS.However, many patients with AS and coexisting conditions are not candidates for surgical aortic valve replacement. In the Euro Heart Survey 33% of 216 patients >75 years presenting with symptomatic severe AS were not referred for surgery. (6) Transcatheter aortic valve implantation (TAVI) is an alternative, less invasive treatment for high risk patients with symptomatic severe AS. In the absence of anatomical contraindications, transfemoral approach is the preferred access route with a procedural success rate of >95%. (7)(8)(9)(10) In selected patients, TAVI reduced the rates of

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Section: Discussionsupporting

confidence: 74%

“…data. (7)(8)(9)12,18) Rapid ventricular pacing is helpful during both BVP and valve deployment. Particular care was taken to limit screening time but despite this it was still more than 30 minutes which is not unexpected in view of the challenging nature of the procedure and our initial inexperience.…”

Section: Discussionmentioning

confidence: 99%

Transcutanous aortic valve replacement with Medtronic CoreValve in a publicprivate partnership hospital complex

Theron¹,

Brown²,

Smit³

et al. 2017

SAHJ

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“…[2][3][4][5] Transcatheter aorticvalve replacement (TAVR) has emerged as an alternative therapy in high-risk patients with aortic stenosis. [6][7][8][9][10] Observational registries from various countries have reported 1-month and 1-year outcomes after TAVR, [11][12][13][14] but there are limited long-term follow-up data. 15 The Placement of Aortic Transcatheter Valves (PARTNER) trial was a randomized trial comparing TAVR with standard-of-care therapies in highrisk patients with aortic stenosis.…”

Section: Discussionmentioning

confidence: 99%

Two-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement

Kodali¹,

Williams²,

Smith³

et al. 2013

Survey of Anesthesiology

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340

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“…7,8 The procedures were performed according to standard local hospital practices, which included the selection of access location (transfemoral, or subclavian), the type of access (surgical cutdown or completely percutaneous), and the type of anesthesia (GA or non-GA). Procedural characteristics analyzed for the comparisons between anesthesia groups included access type and site, procedure duration, fluoroscopy time, quantity of contrast agent used, procedural complications, and length and type of hospital stay.…”

Section: Methodsmentioning

confidence: 99%

Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study)

Brecker

Bleiziffer

Bosmans

et al. 2016

The American Journal of Cardiology

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Transcatheter aortic valve implantation (TAVI) has become the standard of care for many patients with symptomatic severe aortic stenosis who are at increased risk of morbidity and mortality during surgical aortic valve replacement. However, there is still no general consensus regarding the use of general anesthesia (GA) versus local anesthesia with sedation (non-GA) during the TAVI procedure. Using propensity score matching analysis, we analyzed the characteristics and outcomes of patients undergoing TAVI with either GA (n=245) or non-GA (n=245) in the fully monitored, international, CoreValve ADVANCE Study. No statistically significant differences existed between the non-GA and GA groups in all-cause mortality (25.4% vs. 23.9%, p=0.78), cardiovascular mortality (16.4% vs. 16.6%, p=0.92), or stroke (5.2% vs. 6.9%, p=0.57) through 2-year follow up. Major vascular complications were more common in the non-GA group. Total hospital stay was similar between the 2 groups. Conversion from non-GA to GA occurred in 13 patients (5.3%) due to procedural complications in 9 patients and discomfort or restlessness in 4 patients. The majority of the procedural complications were related to valve positioning or vascular issues. Two of the 13 converted patients died during the procedure. Both GA and non-GA are widely used in real-world TAVI practice, and the decision appears to be guided by only a few patient-related factors and dominated by local and national practice. The outcomes of both anesthesia modes are equally good. When conversion from non-GA did occur, the complication requiring GA affected outcomes.Key words: severe aortic stenosis, transcatheter aortic valve replacement; anesthesia; real-world clinical trial 3 Transcatheter aortic valve implantation (TAVI) has become standard of care for patients with symptomatic severe aortic stenosis at extreme or high risk for surgery. 1 In practice, even lower risk patients are already being treated, while at least 3 TAVI clinical trials are assessing the role of the therapy in patients considered at only intermediate risk from surgical AVR. It is therefore likely the number of patients treated with TAVI will increase, requiring additional numbers of operators and hospitals. Concurrently, the procedure is becoming less complex. Smaller sheath sizes, a reduced need for rapid pacing and balloon valvuloplasty, availability of repositionable and recapturable valves, and decreased reliance upon intraprocedural transesophageal echocardiography will herald a new era of TAVI. A significant proportion of procedures are already being performed using local anesthesia with sedation. Others have reported potential benefits of using local anesthesia, including shorter intensive care unit and overall hospital stays, less hemodynamic instability, and less need for vasopressors. [2][3][4][5] It is likely that the proportion of patients treated in this manner will increase. In the ADVANCE study 6 , patients were treated according to best local practice in experienced centers, and a signif...

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Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) CoreValve ReValving System: results from the multicentre, expanded evaluation registry 1-year following CE mark approval

Cited by 589 publications

References 23 publications

Transcutanous aortic valve replacement with Medtronic CoreValve in a publicprivate partnership hospital complex

Transcutanous aortic valve replacement with Medtronic CoreValve in a publicprivate partnership hospital complex

Two-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement

Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study)

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