The Heart Team and the minimalist approach to TAVR today Is there a conflict? G T Stavridis MD FETCS Onassis Cardiac Surgery Ctr.

Transcription

1 The Heart Team and the minimalist approach to TAVR today Is there a conflict? G T Stavridis MD FETCS Onassis Cardiac Surgery Ctr.

2 DISCLOSURES Conflicts of interest: none

3 Minimalist approach (MA) Cath lab Conscious sedation TTE TF Surgeon??? vs Hybrid OR General anaesthesia TOE Any access Present. Available!!???

4 Additionally to safety first AIM FOR greater physician and patient satisfaction better clinical care improvements in health status increased survival

5 - H-T as a cornerstone

6 Η-Τ countless Amalgamate diverse mentality Efficient and effective patient information Administrative support Remuneration of services- Reimbursement Risk becoming a perfunctory process

7 Performing TAVR catheter-based skills for device delivery and placement imaging expertise for correct device positioning follow-up assessments Surgical (????) expertise for access...(90% TF) Post operative care

8 Perioperative results and complications in 15,964 transcatheter aortic valve replacements: prospective data from the GARY registry. Walther T et al J Am Coll Cardiol. 2015;65: # TAVR patients 5% intraoperative SEVERE complications* (death, conversion, mechanical support, dissection) 4,7% intraoperative technical complications (repositioning, retrieval, embolization) 40% mortality if severe complication* overall the perioperative mortality was 5.2%.

9 Minimalist approach (MA) FEASIBLE TAVI by centres 1432 with patients and without an on-site cardiac surgery 12% (178) no surgeon on site programme: 6% mortality preliminary (vs 8%) 95% (vs experience 98%) procedural from success the German TAVI registry. Eggebrecht H et al EuroIntervention. 2014;10: Minimalist transcatheter aortic valve replacement: the new FEASIBLE standard for 94% surgeons procedural success and cardiologists using transfemoral patients access? Jensen HA et al J Thorac Cardiovasc Surg. 2015;150:833-9.

10 Transfemoral transcatheter aortic valve insertion-related intraoperative morbidity: Implications of the minimalist approach. Minimalist approach (MA) Greason KL et al (Mayo Cl) J Thorac Cardiovasc Surg. 2016;151: #215 TF patients 10% intraoperative morbidity (tamponade,embolization and 50% major vascular injury) the type of complication was not predictable the perioperative mortality was very low at only 0.9%.

11 Minimalist approach (MA) TAVI at institutions without cardiovascular surgery departments: why? Mylotte D et al EuroIntervention. 2014;10: TAVI should not be performed, in any setting, without : - appropriate team training - sufficient procedural volume - demonstration of outcomes similar to national benchmarks Difference of visiting a medico-surgical vs a no-surgical hospital Selecting less challenging cohort Continuous care even after the departure of the surgeon(s) Need to centralize care for high risk patients or just practice makes perfect?? As TAVI technology is applied to lower-risk cohorts, the availability of surgical services will become of even greater importance No clear evidence at the moment

12 If you were admitted to hospital tomorrow in any country... your chances of being subjected to an error in your care would be something like 1 in 10. Your chances of dying due to an error in health care would be 1 in 300 a risk of dying in an air crash of about 1 in 10 million passengers Liam Donaldson About 100,000 hospitals worldwide now use the WHO's surgical safety checklist, which the agency said has been shown to reduce surgery complications by 33% percent and deaths by 50 %. If the checklist is effectively used worldwide, an estimated 500,000 deaths could be prevented each year, it says.

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14 3M TAV R ST UDY DESIGN To evaluate the efficacy, feasibility and safety of next day discharge home in patients undergoing balloon expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway Patients with severe symptomatic AS undergoing elective transfemoral TAVR Considered at increased surgical risk by the Heart Team Vancouver 3M Clinical Pathway (n = 400) Meets all general, anatomical, functional, and peri-procedural exclusion criteria COMPLETE REVASCULARIZATION Staged PCI of all suitable non-culprit lesions (< 45 days) Standard TAV R (n = 800) All remaining patients at all sites Standard Care Primary Outcomes: All-cause mortality and major stroke (modified Rankin Scale of 2 or more) at 30 days AND the proportion of patients who are discharged the next day Secondary Outcomes: each component of the primary endpoint; death or non-fatal stroke at 1 year; 30 day major vascular complications/life-threatening bleed/hospital readmission/repeat procedure for valve related dysfunction/stage 3 acute kidney injuries (AKIN classification); periprocedural MI, conversion to GA/intubation; KCCQ and SF-12 at 2 weeks, 30 days, and 1 year

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16 Thank you!!