Trials Focused on Aortic Valve Disease

SCOPE I: One-Year Results From a Randomized Trial of Self-Expanding vs. Balloon-Expandable TAVR¹
Presented by Dr. Thomas Walther

Key Question

• To evaluate 1-year clinical, functional, and echocardiographic-derived outcomes between the self-expandable ACURATE neo (Boston Scientific; Marlborough, MA) first-generation transcatheter aortic valve replacement (TAVR) bioprostheses with the balloon-expandable SAPIEN 3 (Edwards Lifesciences; Irvine, CA) TAVR bioprostheses in patients undergoing transfemoral TAVR.

Characteristics

• A total of 739 patients was enrolled in the trial across 20 centers in Europe, with an average age of 83 years, and an intermediate risk population with Society of Thoracic Surgeons (STS) Predicted Risk of Mortality scores of 3.7% versus 3.4% between the ACURATE neo and SAPIEN 3 groups, respectively.
• A total of 372 patients was randomized to the ACURATE neo arm and 367 patients to the SAPIEN 3 arm, with a completed follow-up at 1 year of 96% versus 97% between the 2 groups.

Key Findings

• Safety and efficacy endpoints at 30 days (all-cause death, any stroke, life-threating or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury, valve-related dysfunction requiring repeat procedure, rehospitalization for valve-related symptoms or heart failure, moderate or severe paravalvular leak, or prosthetic valve stenosis) did not meet the non-inferiority criteria (24% vs. 16%; p = 0.42) in the previous analysis driven by stage 2/3 acute kidney injury and moderate to severe paravalvular regurgitation in the ACURATE neo group.
• There were no significant differences at 1 year between the ACURATE neo arm and the SAPIEN 3 arm in terms of all-cause death (11.1% vs. 8.1%; hazard ratio [HR] 1.32; 95% confidence interval [CI], 0.82-2.12), all-cause death or disabling stroke (12.5% vs. 9.2%; HR 1.28; 95% CI, 0.81-2.0), all-cause death or stroke or rehospitalization (21.3% vs. 19.6%; HR 1.05; 95% CI, 0.76-1.45).
• There were higher effective orifice areas and lower mean gradients (7.2 mm vs. 11.5 mm; p < 0.001) in the ACURATE neo arm than the SAPIEN 3 arm.
• The rate of moderate and severe aortic regurgitation was more in the ACURATE neo arm (8.9% vs. 3.6%; p = 0.006) compared with the SAPIEN 3 arm.

Implications

• Although 30-day data did not meet the non-inferiority criteria, there were improvements in the hemodynamic profile at 1 year in the ACURATE neo group versus the SAPIEN 3 group. Rates of moderate to severe aortic regurgitation remained higher in the ACURATE neo group, which was consistent with 30-day aortic regurgitation results.
• Between the 2 groups, 1-year clinical and functional outcomes were similar, although all-cause mortality was numerically higher in the ACURATE neo group, which did not reach statistical significance.
• Extended follow-up will help to determine the long-term valve durability and performance of the ACURATE neo valve system. In addition, the newer-generation ACURATE neo2 valve system may decrease the rates of paravalvular regurgitation due to changes in the annulus seal following deployment, and outcomes with this device will be assessed in upcoming trials.

SCOPE 2: A Randomized Trial of Two Self-Expanding TAVR Bioprostheses²
Presented by Dr. Corrado Tamburino

Key Question

• To compare and assess the clinical outcomes of two self-expanding supra-annular TAVR bioprostheses: the first-generation ACURATE neo (Boston Scientific; Marlborough, MA) and the CoreValve Evolut R/Pro (Medtronic; Minneapolis, MN).

Characteristics

• From April 2017 to April 2019, 23 centers in 6 countries enrolled patients.
• Patients ≥75 years old with severe symptomatic aortic stenosis (AS) who underwent evaluation by local heart team and referred for TAVR were randomly assigned to either the ACURATE neo or CoreValve Evolut R/Pro bioprostheses.
• A total of 796 patients was included, with 398 patients in the ACURATE neo arm and 398 patients in the CoreValve Evolut R/Pro arm.
• Average age was 83.2 ± 4.3 years with an average STS score of 4.6%.
• Primary endpoint for non-inferiority was all-cause death or stroke at 1-year follow-up.
• Secondary endpoint powered for superiority was new permanent pacemaker implantation within 30 days of valve implantation.

Key Findings

• At 1-year follow-up, the primary endpoint of all-cause death or stroke occurred in 15.8% patients in the ACURATE neo arm versus 13.9% in the CoreValve Evolut R/Pro arm, with an absolute risk difference of 1.8% and a one-sided 95% upper confidence limit of 6.1% that did not meet noninferiority for the ACURATE neo compared with the CoreValve Evolut R/Pro (p = 0.055 for noninferiority).
• Secondary endpoint of 30-day new permanent pacemaker implantation rates was higher at 18.0% in the CoreValve Evolut R/Pro arm versus 10.5% for the ACURATE neo arm, establishing superiority for new pacemaker implantation for ACURATE neo compared with CoreValve Evolut R/Pro with an absolute risk difference of -7.5% (95% CI, -12.4% to -2.6%; p = 0.003). At 1 year, the proportion of patients who received new permanent pacemaker implantation remained significantly lower in the ACURATE neo group compared with the CoreValve Evolut R/Pro group (11% vs. 18%; p = 0.004).
• Higher rates of cardiac death were observed in the ACURATE neo arm compared with the CoreValve Evolut R/Pro arm at 30-day (2.8% vs. 0.8%; p = 0.03) and 1-year (8.4% vs. 3.9%; p = 0.01) follow-up.
• There was a higher degree of aortic regurgitation rated as moderate or severe at 30 days in the ACURATE neo group (10% vs. 3%; p = 0.002).

Implications

• This marks the second negative trial after SCOPE I for the ACURATE neo valve due to not meeting non-inferiority criteria for the primary endpoint of all-cause death or stroke.
• Based on SCOPE 2 trial results, in patients with symptomatic severe AS in the intermediate STS risk category, ACURATE neo has a higher risk of all-cause death, cardiac death, and moderate to severe paravalvular leak and a lower risk of pacemaker compared with the CoreValve Evolut R/Pro prosthesis.
• Head-to-head clinical trials such as these are extremely crucial in evolving the field of TAVR and understanding the right prosthesis for the right patient.

SOLVE-TAVI: One-Year Outcomes of a Factorial Randomized Trial of Self-Expandable vs. Balloon-Expandable TAVR and General vs. Local Anesthesia³
Presented by Dr. Hans-Josef Feistritzer

Key Question

• To evaluate 1-year outcomes between self-expandable CoreValve Evolut R (Medtronic; Minneapolis, MN) and balloon-expandable SAPIEN 3 (Edwards Lifesciences; Irvine, CA) valves along with a comparison of conscious sedation versus general anesthesia in patients referred for TAVR due to severe AS.

Characteristics

• A 2x2 factorial trial design involving patients with severe symptomatic AS, intermediate to high risk, randomized to TAVR with either SAPIEN 3 or CoreValve Evolut R and to either conscious sedation or general anesthesia.
• A total of 447 patients was enrolled in the trial, with an average age of 81.6 years, with STS scores of 7.7% versus 7.6% between the 2 groups.
• Randomization occurred in a 1:1 fashion, with 219 patients randomized to TAVR with SAPIEN 3 and 219 patients randomized to TAVR with CoreValve Evolut R. In addition, 218 patients were randomized to conscious sedation and 220 patients were randomized to general anesthesia.
• Primary endpoint for SAPIEN 3 versus CoreValve Evolut R included 1-year all-cause mortality, stroke, moderate or severe aortic insufficiency, and rates of 30-day permanent pacemaker implantation with secondary endpoints of device success, contrast use, vascular complications, and mean gradients of >20 mmHg at 1-month follow-up.
• Primary endpoint for conscious sedation versus general anesthesia included all-cause mortality, stroke, myocardial infarction, infection necessitating use of antibiotics, and acute kidney injury at 30 days with secondary endpoints of moderate to severe paravalvular regurgitation, need for vasoactive medications, hospital stay duration, and intensive care duration.

Key Findings

• Within the SAPIEN 3 versus CoreValve Evolut R cohort, the primary endpoint was seen in 38.3% versus 40.4% (p = 0.66), respectively, which was statistically non-significant.
• Individual components of the primary endpoint were not different except for the stroke rate, which was higher in the SAPIEN 3 arm versus the CoreValve Evolut R arm (6.1% vs. 0.8%; p = 0.013).
• Median mean and peak aortic valve gradients were lower at 1 year in the CoreValve Evolut R arm (6 and 12 mmHg vs. 10 and 19 mmHg, respectively; p < 0.001 and p < 0.001) compared with the SAPIEN 3 prosthesis.
• Within the conscious sedation versus general anesthesia arm, there were no significant differences in 1-year outcomes between the 2 groups.

Implications

• In an intermediate to high risk population undergoing TAVR with balloon expandable versus self-expandable valves, there was no difference in all-cause mortality, with a higher incidence of stroke and higher mean pressure gradient observed in the balloon-expandable group at 1 year. The rates of stroke in the SAPIEN 3 arm in this trial may be an outlier, given that all the other trials in this population have demonstrated a stroke rate of <3% to 4%.
• There was no difference in clinical outcomes in patients undergoing TAVR with either conscious sedation or general anesthesia at 1-year follow-up. However, the cost difference in resource utilization was not evaluated in this trial.

TRANSIT: Treatment of Failed TAVR With TAVR⁴
Presented by Dr. Luca Testa

Key Question

• To evaluate procedural and clinical outcomes related to TAVR in TAVR, as well as elucidate the reasons for failed initial TAVR and determine the selection criteria of the second TAVR prosthesis.

Characteristics

• Across Europe, North America, South America, and the Middle East, 28 centers participated, with 172 cases meeting inclusion criteria out of over 400,000 TAVR procedures performed since 2008.
• Mean age was 79.9 ± 7.9 years, with 73.5% of patients New York Heart Association (NYHA) Class III/IV with STS score of 6.1 ± 5.7.

Key Findings

• Indication for repeat TAVR was index TAVR valve stenosis in 57 patients (33%), regurgitation in 97 patients (56%), and mixed in 18 patients (11%).
• CoreValve (Medtronic; Minneapolis, MN) and SAPIEN XT (Edwards Lifesciences; Irvine, CA) bioprostheses accounted for the majority of degenerated TAVR valves.
• For second TAVR, operators chose self-expanding prosthesis in the majority of cases (61%), and of these, 83% were CoreValve.
• Total device success rate per Valve Academic Research Consortium-2 criteria was 79%, with failure due to residual post-second TAVR stenosis (14%) or regurgitation (7%).
• In-hospital mortality was 4.1%, and rate of vascular complications was 2.3%. The rate of cerebrovascular events was 3.5%, most often in the mixed physiology group.
• At 30-day follow-up, overall mortality was 7% with no cardiovascular deaths, and 10% at 1-year with a 1-year cardiovascular mortality of 5.8%.

Implications

• TAVR in TAVR may be a viable option as we move toward more low and intermediate risk AS population. However, risk of coronary obstruction, type of second TAVR prosthesis to be used, and coronary re-access across multiple stent frames need to be strategically considered and require future studies.

PARTNER 2: Aortic Valve-in-Valve Registries: 5-Year Outcomes⁵
Presented by Dr. Rebecca T. Hahn

Key Question

• To evaluate the 5-year outcomes for patients undergoing valve-in-valve TAVR following surgical bioprosthetic valve implantation.

Characteristics

• Prospective multicenter registry database.
• Inclusion criteria included patients who were suitable for either 23 or 26 mm SAPIEN XT (Edwards Lifesciences; Irvine, CA) implantation due to symptomatic severe AS or regurgitation of a prior bioprosthetic surgical aortic valve who were at high risk for repeat surgical replacement.
• Exclusion criteria included another prosthetic heart valve in a position other than the aortic valve or a surgical valve size <21 mm.
• A total of 365 patients was analyzed from the registry database, with an average age of 78.9 ± 10.2 years and an average STS score of 9.1 ± 4.7.

Key Findings

• The majority of patients had a surgical bioprosthesis over 10 years old (66%), with failure most often due to valve stenosis (55%); 93.1% had a stented bioprosthesis and 6% had a homograft.
• Surgical bioprosthesis valve size ranged from 23 to 25 mm in 60.8% of patients.
• Sapien XT 23 mm was implanted in majority of the cases (69%).
• Mortality at 5 years in the valve-in-valve cohort was 50.6%. In comparison, 5-year mortality in PARTNER 2A intermediate risk native AS cohort was 45.9% and 73% in the PARTNER 2B inoperable cohort.
• Mortality at 5 years was lower in patients with valve-in-valve 26 mm versus 23 mm SAPIEN XT (40.1% vs. 53.3%; p=0.01), though this may be related to an older population with more coronary heart disease, lower baseline valve area, and higher gradients in the 26 mm SAPIEN XT group.
• At 5 years, rates of stroke were 10.5% in the valve-in-valve cohort.
• Mean gradients, hemodynamic stability, and Doppler velocity index remained stable at 5 years with low rates of paravalvular regurgitation comparable to intermediate risk, native AS TAVR patients.

Implications

• Rate of 5-year valve-in-valve TAVR mortality remains high but is similar to an intermediate risk native valve TAVR cohort (PARTNER 2A).
• Hemodynamic and functional parameters are stable in valve-in-valve TAVR throughout the 5-year follow-up period while maintaining similar rates of hemodynamic valve deterioration versus the native intermediate risk cohort in PARTNER 2A.
• This study provides important information regarding the long-term outcomes of valve-in-valve TAVR procedures. Further outcomes based on self-expanding prosthesis need to be evaluated.

Trials Focused on Cerebral Protection During TAVR

REFLECT II: A Randomized Trial of a Cerebral Embolic Protection Device During TAVR ⁶
Presented by Dr. Jeffrey Moses

Key Question

• To evaluate the safety and efficacy of TriGUARD 3 (Keystone Heart; Tampa, FL), a self-stabilizing cerebral embolic deflection filter, in reducing adverse clinical and neurological events in patients undergoing TAVR.

Characteristics

• Patients with severe native AS undergoing transfemoral TAVR at 51 centers across 7 countries were enrolled in the trial.
• In Phase I, patients who met the eligibility criteria were randomized 2:1 to the first-generation TriGUARD HDH device versus usual care (REFLECT I). In Phase II, patients who met the eligibility criteria were randomized to 2:1 second-generation TriGUARD 3 device versus usual care (REFLECT II).
• REFLECT II final analysis population included 283 patients: 41 roll-in, 121 randomized to the TriGUARD 3 arm, and 121 to the control arm (58 patients randomized in Phase II and 63 pooled from REFLECT Phase I)
• Average age was 80 years with an average STS score of 4.6% in both arms.
• Primary composite 30-day safety endpoint included the following. The endpoint was compared with a performance goal of 34.4%:
  • All-cause mortality, stroke, coronary obstruction requiring intervention, valve dysfunction requiring intervention (per Valve Academic Research Consortium-2 criteria), life-threatening or disabling bleeding, kidney injury stage 2/3
• Primary efficacy endpoint was a hierarchical composite of the following:
  • All-cause mortality or stroke at 30 days
  • National Institutes of Health Stroke Scale worsening from baseline to 2-5 days.
  • Freedom for cerebral ischemic lesions as assessed by Corelab via diffusion-weighted magnetic resonance imaging at 2-5 days
  • Total volume of cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging at 2-5 days

Key Findings

• Following enrollment of 179 of the 225 patients planned to be randomized, the sponsor suspended the trial enrolment and proceeded with marketing application.
• Successful deployment of the device occurred in 100% of the patients.
• Primary safety endpoint in the TriGUARD 3 group was 22.5% versus performance goal of 34.4%, with p value for non-inferiority of 0.0001. Noteworthy, rate of major vascular complications (7% vs. 0%), and life-threating or disabling bleeding (5.7% vs. 0%) was higher in the TriGUARD 3 group versus the control group, although attributed primarily to TAVR-related vascular complications.
• However, the superiority for primary efficacy endpoint was not met:
  • All-cause mortality or stroke at 30 days of 9.8% in the TriGUARD 3 arm versus 6.7% in controls (p = 0.47)
  • National Institutes of Health Stroke Scale worsening pre-discharge of 14.1% in the TriGUARD 3 arm versus 7.6% in controls (p = 0.176)
  • Cerebral ischemic lesions of 85.0% in the TriGUARD 3 arm versus 84.9% in controls (p = 1.00)
  • Total cerebral lesion volume of 215.4 mm2 in TriGUARD 3 arm versus 188.09 mm2 in controls (p = 0.40)

Implications

• REFLECT II demonstrated that the TriGUARD 3 device is safe compared with the historical controls; however, the study did not demonstrate superiority of the TriGUARD 3 device in reducing hard clinical endpoints like all-cause mortality or stroke at 30-day follow-up.
• Future clinical trials in the embolic protection arena are needed to demonstrate reduction in hard clinical endpoints, especially stroke, with these devices.

STS/ACC TVT Registry: Cerebral Embolic Protection and TAVR Outcomes⁷
Presented by Dr. David J. Cohen

Key Question

• To evaluate outcomes from the STS/ACC Transcatheter Valve Therapy Registry (TVT Registry) using the cerebral embolic protection SENTINEL (Boston Scientific; Marlborough, MA) device in patients undergoing TAVR.

Characteristics

• Trial design was an observational study between January 2018 and December 2019 for all patients undergoing transfemoral TAVR (inclusive of all devices) for trileaflet, bicuspid, and valve-in-valve procedures with versus without cerebral embolic protection included in the TVT Registry.
• Exclusion criteria included emergent procedures, alternative access beyond transfemoral, low-volume centers with <20 TAVR per year, and concurrent mitral valve procedures.
• Primary endpoint was in-hospital stroke (hospital-reported, centrally adjudicated).
• Secondary endpoints included in-hospital stroke or transient ischemic attack, in-hospital death, in-hospital death or stroke, TAVR device success (Valve Academic Research Consortium-2 defined), and 30-day stroke or death.
• Instrumental variable and propensity-weighted analysis were performed for both the primary and secondary endpoint analyses.

Key Findings

• A total of 123,186 patients was included, with 12,409 patients undergoing transfemoral TAVR with cerebral embolic protection versus 110,777 without cerebral embolic protection.
• There was significant variation in the cerebral embolic protection use across centers; 66% of the sites contributing to the TVT Registry never used cerebral embolic protection over a 2-year period, and 5% of the sites used cerebral embolic protection in >50% of their cases.
• Instrumental Variable Analysis:
  • Rate of in-hospital stroke in the cerebral embolic protection group was 1.39% versus 1.54% in the non-cerebral embolic protection group (95% CI, 0.96-1.13; p = 0.41), which was statistically non-significant.
  • In terms of secondary endpoints, there was no difference in the in-hospital rates of death or stroke, major bleeding, or valve device success and no difference in the rates of 30-day death or stroke.
• Propensity-Weighted Analysis:
  • Rate of in-hospital stroke in the cerebral embolic protection was 1.30% versus 1.58% in the non-cerebral embolic protection arm (95% CI, 0.69-0.97; p=0.02), which was statistically significant.
  • In terms of secondary endpoints, in-hospital death and stroke and 30-day death and stroke analysis were noted to be lower in patients who received cerebral embolic protection device (in-hospital death or stroke: 2.1% vs. 2.5%; p = 0.03; 30-day stroke: 1.9% vs. 2.2%; p = 0.04; 30-day death: 1.7% vs. 2.2%; p = 0.01).

Implications

• Instrumental variable analysis showed no significant reduction in in-hospital or 30-day stroke/death with use of cerebral embolic protection during TAVR, whereas the propensity-weighted analysis showed modest reduction in stroke; however, there are more confounding variables within this analysis.
• These findings suggest clinical equipoise. Further randomized trials including PROTECTED TAVR (Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement; NCT04149535) will help us further evaluate the role of embolic protection devices in patients undergoing TAVR.

Trials Focused on Mitral Valve Disease

MITHRAS: A Randomized Trial of ASD Closure After Transcatheter Mitral Valve Repair⁸
Presented by Dr. Philipp Lurz

Key Question

• To evaluate the changes in functional capacity with iatrogenic atrial septal defect (ASD) closure following transseptal transcatheter mitral valve repair versus no closure and conservative treatment.

Characteristics

• Patients underwent transthoracic and transesophageal echocardiograms at 30 days following transcatheter mitral valve repair and were enrolled if iatrogenic ASD was present based on left to right shunting and fraction of pulmonary to systemic perfusion ratio ≥1.3 (Qp/Qs ratio).
• Exclusion criteria were based inter-atrial shunt prior to transcatheter mitral valve repair, no reduction in mitral regurgitation (MR) following transcatheter mitral valve repair, pre-planned subsequent valvular intervention, history of malignancy with <12 months expected survival, and anatomical considerations excluding iatrogenic ASD closure.
• A total of 80 patients was enrolled at a single center, with 40 assigned to the iatrogenic ASD arm and 40 assigned to the conservative treatment arm with iatrogenic ASD closure performed with Figulla Flex II (Occlutech International AB; Helsingborg, Sweden) within 3 days following randomization.
• Average age was 77 ± 9 versus 76 ± 10 years in each arm, with a EuroSCORE of 4.9 and 5.5, respectively.
• Primary endpoint was change in 6-minute walk testing from the time of randomization and at 5-month follow-up.
• Secondary endpoints included changes in peripheral edema, NYHA functional class, N-terminal pro-B-type natriuretic peptide, and death or hospitalization for heart failure.

Key Findings

• Iatrogenic ASD closure was successful in all patients with Qp:Qs of 1.0 at follow-up.
• 6-minute walk test did not show any significant differences between the 2 arms of the trial (at randomization time point, iatrogenic ASD arm vs. control: 272 ± 124 vs. 302 ± 124 m and at follow-up 276 ± 119 vs. 301 ± 118 m; ∆ iatrogenic ASD occlusion 5 ± 89 m vs. ∆ control group -1 ± 83 m; p = 0.75, p = 0.92, p = 0.76, respectively). There were no statistically significant differences observed in the secondary endpoints.
• In the conservative treatment arm, 46% had a change in the Qp/Qs ratio from 1.5 to 1.3 (p = 0.02) at 5-month follow-up.

Implications

• Based on this small, single-center randomized trial, iatrogenic ASD closure following transcatheter mitral valve repair does not appear to have any benefit in terms of improving 6-minute walk test or other clinical midterm outcomes.

MitraBridge: Outcomes of MitraClip Treatment as Bridge Therapy to Heart Transplantation⁹
Presented by Dr. Cosmo Godino

Key Question

• To evaluate outcomes of patients with end stage/advanced heart failure with severe MR undergoing MitraClip (Abbott Vascular; Abbott Park, IL) intervention as a bridging strategy to heart transplant.

Characteristics

• Multicenter registry of 119 patients with end stage/advanced heart failure with severe MR from 17 centers in Europe and Canada who were treated with MitraClip in 1 of 3 arms:
  • 31 patients on the active transplant list (pure bridge)
  • 54 patients awaiting clinical decision to transplant (bridge to decision)
  • 34 patients not yet on the transplant list due to potentially reversible contraindication to heart transplant and were being bridged to candidacy
• Median age was 58 years, and patients had a median left ventricular ejection fraction of 26% with an indexed left ventricular end diastolic volume of 122.5 ml/m2.
• Primary composite endpoint was 1-year adverse events of all-cause death, urgent transplantation or left ventricular assist device implantation, or first rehospitalization for heart failure.
• Secondary endpoint was 1-year first rehospitalization for heart failure.

Key Findings

• MitraClip procedural success was 87.5%, as per Mitral Valve Academic Research Consortium criteria, and 30-day survival was 100%.
• At 1 year, 2/3 of the patients remained free of the primary composite endpoint, with 3 patients lost to follow-up, 13 awaiting decision, 6% undergoing urgent transplantation, 18% undergoing left ventricular assist device implantation, and death in 4.5% of patients.
• At a median of 532 days of time of last follow-up, 15.5% underwent elective transplantation, 15% remained on transplant waitlist, and 23.5% were delisted due to no longer needing transplant due to improvement in clinical condition.

Implications

• MitraClip for patients with advanced/end-stage heart failure was a technically safe procedure, with approximately 2/3 of patients remaining free from the composite adverse event primary endpoint at 1 year.
• In light of negative MITRA-FR trial (partly attributed to more dilated ventricles and worse ejection fraction), this study is hypothesis generating and can open doors for several other mitral therapies in the pipeline for patients with low ventricular ejection fraction and severe MR.

Global EXPAND: One-Year Outcomes With Third Generation MitraClip NTR and XTR Systems¹⁰
Presented by Dr. Saibal Kar

Key Question

• To evaluate outcomes of the MitraClip NTR/XTR (Abbott Vascular; Abbott Park, IL) systems, which were designed to improved device delivery, and to assist in leaflet grasping via the longer clip arms of the XTR system from 9 mm to 12 mm.

Characteristics

• Prospective, multi-center, international, single-arm study of 57 centers across the United States and Europe.
• A total of 1,041 patients with an average age of 77.3 ± 9.7 with mean STS for repair of 6.3% was enrolled in the study: 1,027 (98.6%) patients were discharged post-procedure, with 953 (91.5%) completing 30-day follow-up, 866 (83.1%) completing 6-month follow-up, and 722 (69.3%) completing 12-month follow-up, which represented a rate of 84% of the original study population.
• Etiology of regurgitation was primary degenerative in 50.5% patients.
• Outcomes analyzed were MR severity, procedural outcomes, major adverse cardiovascular events, survival and heart failure hospitalization, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and NYHA functional classification.

Key Findings

• Regarding the clip delivery system, 45% of patients underwent repair with XTR, 40.4% with NTR, and 14.7% with both NTR and XTR.
• In primary MR, the rate of XTR use was higher than in secondary MR: 46.2% versus 41.2%.
• The following had ≤1+ MR at 1-year follow-up:
  • 89.2% in patients in total cohort
  • 84.5% in patients with primary MR
  • 93% in patients with secondary MR
• Following intervention, 80.3% of patients were NYHA Class I/II, with patients with both primary and secondary MR showing improvements in KCCQ scores.
• Hospitalizations at 1 year for the entire cohort were 18.9%, with rates of hospitalization in patients with primary or secondary MR of 12.2% and 26.0%, respectively (p < 0.001), with a reduction in annualized heart failure hospitalizations from 1 year pre-MitraClip and 1 year post-MitraClip (80% vs. 28%).
• Overall mortality was 14.9% at 1 year, with higher rates of mortality in patients with secondary MR versus primary MR (17.7% vs. 12.5%; p < 0.059).

Implications

• Newer-generation MitraClip systems resulted in post-procedure ≤1+ MR, which was sustained at 1 year, with concurrent improvements in KCCQ score, NYHA classification, and left ventricular remodeling parameters with rates of hospitalization and mortality similar to the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial without added complications related to longer clip arm size of 12 mm.

References

1. Walther T. SCOPE I: One-year outcomes of a randomized trial comparing a self-expanding to a balloon-expandable transcatheter aortic valve (TCTMD.com). October 17, 2020. Available at https://www.tctmd.com/slide/scope-i-one-year-outcomes-randomized-trial-comparing-self-expanding-balloon-expandable. Accessed December 8, 2020.
2. Tamburino C, Bleiziffer S, Thiele H, et al. Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial. Circulation 2020;142:2431-42.
3. Feistritzer H-J, on behalf of the SOLVE-TAVI investigators. A 2 x 2 randomized trial of self-expandable vs balloon-expandable valves and general vs local anesthesia in patients undergoing transcatheter aortic valve implantation: 1-year results. Presented at: TCT 2020. October 16, 2020.
4. Testa L. TRANSIT: Treatment of Failed TAVR With TAVR (TCTMD.com). October 17, 2020. Available at https://www.tctmd.com/slide/transit-treatment-failed-tavr-tavr. Accessed December 8, 2020.
5. Hahn R. Five-Year Follow-Up from the PARTNER 2 Aortic Valve-in-Valve Registries: Clinical Outcomes, Valve Function, and Durability (TCTMD.com). October 17, 2020. Available at https://www.tctmd.com/slide/five-year-follow-partner-2-aortic-valve-valve-registries-clinical-outcomes-valve-function-and. Accessed December 8, 2020.
6. Moses JW. A Randomized Evaluation oF the TriGUARD3™ Cerebral Embolic Protection Device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation The REFLECT II Trial (TCTMD.com). October 15, 2020. Available at https://www.tctmd.com/slide/randomized-evaluation-triguard3tm-cerebral-embolic-protection-device-reduce-impact-cerebral. Accessed December 8, 2020.
7. Cohen DJ. Cerebral embolic protection and TAVR outcomes: results from the TVT Registry. Presented at: TCT 2020. October 16, 2020.
8. Lurz P, Unterhuber M, Rommel KP, et al. Closure of Iatrogenic Atrial Septal Defect Following Transcatheter Mitral Valve Repair: The Randomized MITHRAS Trial. Circulation 2020;Oct 15:[Epub ahead of print].
9. Godino C, Munafò A, Scotti A, et al. MitraClip in secondary mitral regurgitation as a bridge to heart transplantation: 1-year outcomes from the International MitraBridge Registry. J Heart Lung Transplant 2020;39:1353-62.
10. Kar S. Core-Lab Adjudicated Contemporary Clinical Outcomes at 1 Year with MitraClip™ (NTR/XTR) System from Global EXPAND Study (TCTMD.com). October 17, 2020. Available at https://www.tctmd.com/slide/core-lab-adjudicated-contemporary-clinical-outcomes-1-year-mitracliptm-ntrxtr-system-global. Accessed December 8, 2020.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Diabetes and Cardiometabolic Disease, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, Acute Heart Failure, Heart Failure and Cardiac Biomarkers, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Magnetic Resonance Imaging, Exercise, Mitral Regurgitation

Keywords: Cardiac Surgical Procedures, Geriatrics, Heart Failure, Heart Septal Defects, Atrial, Heart Valve Diseases, Mitral Valve Insufficiency, Hospital Mortality, Iatrogenic Disease, Natriuretic Peptide, Brain, TCT20, Transcatheter Cardiovascular Therapeutics, Tricuspid Valve Insufficiency, Walking, Acute Kidney Injury, Aortic Valve Stenosis, Cardiac Surgical Procedures, Cerebral Hemorrhage, Diffusion Magnetic Resonance Imaging, Embolic Protection Devices, Embolism, Geriatrics, Heart Valve Diseases, Hemorrhage, Intracranial Embolism, Ischemic Attack, Transient, Stroke, Transcatheter Aortic Valve Replacement, TCT20, Transcatheter Cardiovascular Therapeutics, Vascular Diseases, Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Stroke, Transcatheter Aortic Valve Replacement, TCT20, Transcatheter Cardiovascular Therapeutics, Acute Kidney Injury, Aortic Valve Stenosis, Cardiac Surgical Procedures, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Stroke, Syncope, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics, TCT20, Vascular Diseases, Transcatheter Cardiovascular Therapeutics, Acute Kidney Injury, Atrial Fibrillation, Anesthesia, Aortic Valve Stenosis, Catecholamines, Conscious Sedation, Geriatrics, Heart Defects, Congenital, Heart Valve Diseases, Heart Valve Prosthesis, Myocardial Infarction, Pacemaker, Artificial, Stroke, Thrombosis, TCT20, Transcatheter Aortic Valve Replacement

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