PARTNER 2A and SAPIEN 3 Cost-effectiveness: Cost-effectiveness of TAVR vs SAVR in Intermediate-Risk Patients With Aortic Stenosis (Presented by David Cohen, MD, MSc)

Key Question

Is transcatheter aortic valve replacement (TAVR) cost-effective in intermediate-risk patients compared with surgical aortic valve replacement (SAVR)?

Characteristics and Key Findings

• Analysis population:
• P2A: TAVR (Edwards [Edwards Lifesciences; Irvine, CA] SAPIEN XT valve; n = 994), SAVR (n = 944)
• S3i: TAVR (SAPIEN 3 valve; n = 1,077), SAVR (n = 936)
• P2A:
• Index hospitalization cost difference was $2,888 (p = 0.014) in favor of SAVR:
• XT-TAVR cost: $61,433 ($3,827 MD fees; $19,417 non-procedural; $38,548 procedural)
• SAVR cost: $58,545 ($5,421 MD fees; $37,409 non-procedural; $16,465 procedural)
• Follow-up costs by interval:
• Discharge to 30 days: $3,806 in favor of TAVR (p < 0.05)
• 30 days to 6 months: $7,160 in favor of TAVR (p < 0.05)
• 6-12 months: $907 in favor of TAVR (p= NS)
• 12-24 months: $668 in favor of SAVR (p = NS)
• Total 2-year cost difference was $6,416 in favor of TAVR (p = -0.014):
• XT-TAVR cost: $107,716 ($61,433 index procedure; $46,284 follow-up)
• SAVR cost: $114,132 ($58,545 index procedure; $55,587 follow-up)
• Over a lifetime horizon, XT-TAVR was projected to be an economically dominant strategy (lifetime cost saving of $7,949; gain of quality-adjusted life-year).

• Results were similar for the S3i trial, with more favorable results with the SAPIEN 3 valve (lifetime cost saving of $9,692; gain of quality-adjusted life-year).

Implications

TAVR appears to be cost-effective in the setting of a randomized clinical trial. Replication of these results in a real-world cohort is needed.

3MTAVR: The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement (Presented by David A Wood, MD)

Key Question

What is the efficacy, feasibility, and safety of next-day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing a prespecified pathway (the Vancouver 3M Clinical Pathway)?

Characteristics and Key Findings

• 411 patients enrolled. Society of Thoracic Surgeons (STS) risk score or ejection fraction were not part of the exclusion criteria.
• Primary outcome: all-cause mortality and stroke at 30 days and the proportion of patients discharged the next day.
• 408 patients were eligible for early discharge.
• 327 discharged next day (2 deaths, 4 withdrawals, 2 lost to follow-up).
• 81 non-next-day discharge (1 death, 0 withdrawals, 2 lost to follow-up).
• 396 patients completed 30-day follow-up (183, 80, and 148 patients in high-, medium-, and low-volume hospitals, respectively).
• Mean STS risk score was 4.9%. All patients underwent SAPIEN 3 or XT valves.
• Mortality or stroke was 2.9% (not affected by hospital volume), next-day discharge was achieved in 80.1% of patients (discharge within 48 hours occurred in 89.5%).
• 30-day all-cause readmission rate was 9.2%, cardiac readmission rate was 5.7% (not different in next-day discharge vs. non-next-day discharge), new pacemaker rate was 5.7%, and post-procedural paravalvular aortic regurgitation > mild occurred in 3.8%.

Implications

A prespecified clinical pathway for transfemoral TAVR allowed next-day discharge in 80.1% of patients in this cohort without an increase in 30-day events compared with other clinical registries.

MITRAL: 30-Day Outcomes of Transcatheter MV Replacement in Patients With Severe Mitral Valve Disease Secondary to Mitral Annular Calcification or Failed Annuloplasty Rings (Presented by Mayra Guerrero, MD)

Key Question

What are the 30-day outcomes of transcatheter mitral valve replacement (MVR) in mitral annular calcification (MAC) or failed surgical ring?

Characteristics and Key Findings

• Observational trial, enrolled 60 patients (30 MAC; 30 failed annuloplasty ring).
• Primary safety endpoints were immediate procedural success (successful access, delivery, and retrieval of the transcatheter valve delivery system, deployment of single valve in correct position, hemodynamic success criteria achieved, and patient left catheterization laboratory/operating room alive) and at 30 days (no device-related adverse events and hemodynamic success criteria achieved).
• Primary effectiveness endpoint was defined as patient returning to pre-procedural setting, no re-hospitalizations or re-interventions for heart failure (HF) or the underlying mitral valve (MV) condition.
• Hemodynamic success criteria: MV area ≥ 1.5 cm2, MV gradient < 10 mmHg, residual mitral regurgitation (MR) ≤ 2+, no increase in aortic insufficiency from baseline, and ≤20 mmHg increase in left ventricular outflow tract (LVOT) gradient from baseline.
• Valve-in-ring:
• Most common device used: Edwards Physio (30%).
• Indication: mitral stenosis 33.3%; MR 56.7%; both 10%.
• STS risk score was 9.1 ± 6.6.
• 100% trans-septal access.
• In-hospital mortality was 6.6% (2/30); 30-day mortality was 6.9% (2/29).
• Immediate technical success was achieved in 70%; 20% required a second valve (all of these patients were alive at 30 days); 10% had 2+ MR.
• Procedural success at 30 days was achieved in 62% of patients.
• 3.4% underwent surgical MVR.
• 75% (out of 24 patients) had no or trace MR at 30 days.
• Valve-in-MAC:
• Indication: mitral stenosis 73.3%; MR 10%; both 16.7%.
• STS risk score was 8.8 ± 8.3.
• If high risk of LVOT obstruction, patients underwent trans-atrial access with anterior mitral leaflet resection.
• 50% underwent trans-septal or trans-apical access, and 50% underwent trans-atrial access.
• In-hospital mortality was 16.7%; 30-day mortality was 19.2%.
• Immediate technical success was achieved in 73.3%; LVOT obstruction occurred in 10%; need for second valve in 3.3%; ≥ 2+ MR in 6.6%; left ventricle perforation in 3.3%; and ventricular septal defect in 3.3%.
• Procedural success at 30 days was achieved in 46%.
• 13.3% required new pacemaker implantation.
• 3.8% had re-intervention with valve-in-valve at 30-day.
• 11.5% had hemolytic anemia at 30 days.
• For trans-atrial transcatheter MVR, pre-emptive alcohol septal ablation weeks prior to the transcatheter MVR was successful in prevention LVOT obstruction.
• 80% (out of 20 patients) had none or trace MR at 30 days.

Implications

In this trial, valve-in-ring was associated with low adverse events and good outcomes at 30 days. However, valve-in-MAC procedures were associated significant morbidity and mortality, thus devices and techniques require further refinement.

INTREPID: 30-Day Outcomes of Transcatheter MV Replacement in Patients With Severe Mitral Regurgitation (Presented by Paul Sorajja, MD).

Key Question

What is the feasibility of transcatheter MVR with the Medtronic (Medtronic, Dublin, Ireland) Intrepid valve?

Characteristics and Key Findings

• 50 patients enrolled.
• Inclusion criteria: severe MR, high surgical risk, mild or no MV calcification, and left ventricular ejection fraction ≥ 20%.
• Exclusion criteria: pulmonary hypertension (pulmonary artery systolic pressure ≥ 70 mmHg), Cr > 2.5 mg/dl, and prior MV intervention.
• MR etiology: 16% primary; 72% secondary; 12% both.
• STS risk score was 6.4 ± 5.5. New York Heart Association (NYHA) Class III/IV was present in 86% of patients.
• Transcatheter MVR was successfully implanted in 98%.
• 30-day mortality 14% (3 apical bleeding, 3 congestive HF, 1 malposition). Beyond 30 days, mortality was 9.8% (4 out of 41 patients).
• 1-year survival was 76.5%. All patients had mild or no MR at 1 year, 79% had NYHA Class I or II, and none had device malfunction, hemolysis, or thrombosis.

Implications

Transcatheter MVR with the Intrepid valve was feasible and resulted in correction of MR. Randomized clinical trials are needed to compare transcatheter MVR with the Intrepid valve with surgical MVR and/or other transcatheter therapies.

TENDYNE: 1-Year Outcomes of Transcatheter MV Replacement in Patients With Severe Mitral Regurgitation (Presented by David WM Muller, MBBS, MD)

Key Question

What is the safety, performance, and usability of the Tendyne (Abbott Vascular; Santa Clara, CA) transcatheter MVR?

Characteristics and Key Findings

• 30 patients enrolled in a multicenter study.
• STS risk score was 7.3 ± 5.7. NYHA Class II (46.7%) or III (53.3%).
• MR severity: 93.1% grade 4+; 6.9% grade 3+.
• MR etiology: 10% primary; 80% secondary; 10% both.
• Of the 30 patients enrolled, 2 had unsuccessful valve implantation, 5 died within a year (4 had cardiac death), and 1 withdrew consent, which resulted in 22 patients completing 12-month follow-up.
• Survival at 1 year was 83% (25/30). HF rehospitalization at 1 year occurred in 10%.
• Valve performance: 3.6% had malposition/paravalvular leak/hemolysis; 3.6% had leaflet thrombosis; 94.7% of patients alive at 1 year had no MR on echocardiography.

Implications

In this early feasibility trial in a selected population, the Tendyne transcatheter MVR is relatively safe with good performance. Further large trials are needed to compare the Tendyne transcatheter MVR with surgical MVR and other transcatheter therapies.

MAVERIC: 6-Month Outcomes of Transcatheter MV Repair in Patients With Severe Secondary Mitral Regurgitation (Presented by Stephen G. Worthley, MBBS, PhD)

Key Question

What is the safety and feasibility of the ARTO (MVRx, Inc.; San Mateo, CA) system that uses transcatheter annular reduction therapy?

Characteristics and Key Findings

• Inclusion criteria: secondary MR ≥ 2+, NYHA Class II-IV, and on optimal medical therapy.
• Exclusion criteria: need for cardiac surgery for other indications.
• 45 patients were enrolled. STS risk score was 3.8 ± 3.4.
• A 100% device success was achieved, with only 2 adverse events during the initial 30 days (1 tamponade, 1 renal failure).
• At 6 months, 3 patients had cardiac death, 1 patient has a stroke, and 1 patient had MV reintervention.
• MR grade at 6 months: 18.4% no MR/trace MR; 39.5% had 1+; 29% had 2+; 13.2 had 3+.

Implications

This study shows the feasibility and safety of the ARTO transcatheter MV repair system. Randomized trials comparing this device with surgical MVR and/or other transcatheter MV interventions are needed.

TRACER: 6-Month Outcomes of Transcatheter MV Neochordal Repair in Patients With Severe Primary Mitral Regurgitation (Presented by James S. Gammie, MD)

Key Question

What is the safety and device performance of the Harpoon (Harpoon Medical, Inc.; Baltimore, MD) MV repair system (beating-heart, image-guided, trans-ventricular, non-resectional MV repair)?

Characteristics and Key Findings

• Inclusion criteria: severe degenerative MR, isolated posterior leaflet prolapse, and good predicted coaptation surface.
• 30 patients were enrolled; 50% had NYHA Class I, 33% had Class II, and 17% had Class III. STS risk score was 0.7 ± 0.7.
• Technical success was achieved in 93%. Conversion to conventional surgery occurred in 2 patients.
• At 30 days, device success was achieved in 90% (27/30). MR reduced to ≤ mild in 89%, moderate in 11%.
• Outcomes: 2 developed new postoperative atrial fibrillation. No cases of mortality, stroke, or renal failure (out to 6 months post-procedure).
• At 6 months, 8% had moderate MR, 8% had severe MR, and the rest had no/mild MR.
• Resultant mean MV gradient was 1.5 ± 0.6 mmHg. MV repair was associated with favorable remodeling: left atrial volume, left ventricle dimensions, and mitral annular area all improved.

Implications

The Harpoon MV repair system is safe and effective. However, optimal patient selection and comparison with conventional MV surgical repair are warranted prior to clinical adoption.

FORMA: 30-Day Outcomes of Transcatheter TV Repair in Patients With Severe Secondary Tricuspid Regurgitation (Presented by Susheel Kudali, MD)

Key Question

What is the safety, device performance, and clinical outcomes at 30 days in patients with severe symptomatic tricuspid regurgitation (TR) treated with the FORMA (Edwards Lifesciences; Irvine, CA) tricuspid transcatheter therapy system?

Characteristics and Key Findings

• Inclusion criteria: ≥2+ functional TR, NYHA Class ≥ II despite optimal medical therapy, and high surgical risk.
• Trial intended to treat 30 patients, enrolled 29 patients (2 had right ventricle perforation, of whom 1 died and 1 underwent conventional surgery).
• 30-day follow-up was available in 25 patients (1 had device migrated, later extracted, and 1 had device extracted due to infection).
• STS risk score was 9.1 ± 6.8. NYHA Class III or IV was present in 86%.
• 24% had pre-existing pacemaker.
• Baseline mean proximal isovelocity surface area (PISA) was 1.2 ± 0.6 cm2. Mean TR volume was 129 ± 66 ml.
• 100% underwent left subclavian vein access.
• Clinical outcomes at 30 days for the 29 enrolled patients: 6.9% died; 3.4% had vascular injury; 6.9% had life-threatening bleeding; 13.8% had major bleeding; 10.3% had device-related cardiac surgery; 10.3% had acute kidney injury ≥ stage II.
• 20/29 (69%) had none of the above clinical outcomes at 30 days.
• Mean two- and three-dimensional effective regurgitant orifice area decreased from 2.1 cm2 to 1.1 cm2. Mean PISA effective regurgitant orifice area decreased from 1.1 cm2 to 0.6 cm2.
• NYHA Class III or IV prevalence decreased from 86% to 28%.

Implications

Transcatheter TR repair using the FORMA system is technically feasible and leads to reduction in TR severity and improved functional capacity. Clinical trials are needed to compare the FORMA system with standard medical therapy and/or other transcatheter interventions.

TRI-REPAIR: 30-Day Outcomes of Transcatheter TV Repair in Patients With Severe Secondary Tricuspid Regurgitation (Presented by Georg Nickenig, MD)

Key Question

What is the performance and safety of the Edwards (Edwards Lifesciences; Irvine, CA) Cardioband System for repair of TR?

Characteristics and Key Findings

• Inclusion criteria: ≥2+ functional TR, annulus diameter ≥ 40 mm with systolic pulmonary artery ≤ 60 mmHg, symptomatic despite optimal medical therapy, left ventricular ejection fraction ≥ 30%, and high risk for surgery.
• 30 patients were enrolled. Euroscore II was 4.2%.
• 86% had NYHA Class III or IV.
• Device deployment was successful in 100%.
• At 30 days, 2 deaths occurred (1 right ventricular failure, 1 bleeding unrelated to the device), 1 had a stroke, 2 had life-threatening bleeding (tamponade, intracranial bleed), and 1 had extensive bleeding.
• On average, there was a 17% reduction in tricuspid valve (TV) septolateral diameter on echocardiography (from mean 44 ± 4 mm to mean 37 ± 5 mm post-intervention). Also, there was 50% reduction in PISA effective regurgitant orifice area, 31% reduction in vena contracta, and 7% improvement in stroke volume at 30 days.
• Functional improvement at 30 days (6-minute walk test increased by a mean of 31 meters; 80% of patients in NYHA Class I or II).

Implications

Transcatheter TR repair using Edwards Cardioband system is technically feasible and leads to reduction in TR severity and improved functional capacity. Clinical trials are needed to compare the Cardioband system to standard medical therapy and/or other transcatheter interventions.

TriValve Registry: Which Patients Undergo Transcatheter Tricuspid Valve Repair? (Presented by Maurizio Taramasso, MD)

Key Question

What are the characteristics and initial clinical results of patients undergoing transcatheter tricuspid valve repair?

Characteristics

• 178 patients enrolled in Europe and North America.
• Mean Euroscore II was 8.7 ± 9; 93% had functional TR, 79% had central TR, 70% had prior HF admission, and 95% had NYHA Class III/IV.
• Trans-valvular tricuspid lead was present in 23.5%.
• Devices used:
• 65% MitraClip (Abbott Vascular; Santa Clara, CA)
• 10% Trialign (Mitralign, Inc.; Tewksbury, MA)
• 8% TriCinch (4Tech Cardio Ltd.; Galway, Ireland)
• 7% Cardioband
• 6% FORMA
• 3% Caval aortic valve implantation
• Isolated TV intervention in 66% of the cases (the other 34% had both TV and MV repaired with MitraClip).

Key Findings

• Procedural success (patient alive + device successfully implanted + TR grade ≤ 2+) occurred in 66.4%.
• 30-day mortality occurred in 2.2% (1 sepsis, 2 HF, and 1 after TV surgery), and 30-day major adverse cardiac and cerebrovascular events occurred in 11.8%.
• NYHA Class III and IV prevalence decreased from 95% to 43%. Ascites prevalence decreased from 28% to 14%. Peripheral edema prevalence decreased from 89% to 42%.
• 1-year survival was 85% in patients who had procedural success and 79% in patients with unsuccessful procedures, with 83% overall survival.

Implications

Early experience with transcatheter TV repair shows promise. Further studies and clinical trials are needed to inform optimal patient selection and establish efficacy of percutaneous TV intervention compared with medical therapy and/or surgical intervention.

Keywords: Transcatheter Cardiovascular Therapeutics, TCT17, Heart Valve Diseases

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