Impact of transcatheter heart valve type on outcomes of surgical explantation after failed transcatheter aortic valve replacement: the EXPLANT-TAVR international registry.

BACKGROUND: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure. AIMS: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV). METHODS: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV. RESULTS: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69). CONCLUSIONS: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.

Feasibility and Outcomes of Mitral Transcatheter Edge-To-Edge Repair in Patients With Variable Degrees of Mitral Annular Calcification.

Background The clinical significance of mitral annular calcification (MAC) in patients undergoing mitral transcatheter edge-to-edge repair is not well understood. There is limited evidence regarding the feasibility, durability of repair, and the prognostic value of MAC in this population. We sought to examine the prognostic value of MAC, its severity, and its impact on procedural success and durability of mitral transcatheter edge-to-edge repair. Methods and Results We reviewed the records of 280 patients with moderate-severe or severe mitral regurgitation who underwent mitral transcatheter edge-to-edge repair with MitraClip from March 2014 to March 2022. The primary end point was cumulative survival at 1 year. Independent factors associated with the primary end point were identified using multivariable Cox regression. Among 280 patients included in the final analysis, 249 had none/mild MAC, and 31 had moderate/severe MAC. Median follow-up was 23.1 months (interquartile range: 11.1-40.4). Procedural success was comparable in the MAC and non-MAC groups (92.6% versus 91.4%, P=0.79) with similar rates of residual mitral regurgitation ≤2 at 1 year (86.7% versus 93.2%, P=0.55). Moderate/severe MAC was associated with less improvement in New York Heart Association III/IV at 30 days when compared with none/mild MAC (45.8% versus 14.3%, P=0.001). The moderate/severe MAC group had lower cumulative 1-year survival (56.8% versus 80.0%, hazard ratio [HR], 1.98 [95% CI, 1.27-3.10], P=0.002). Moderate/severe MAC and Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair were independently associated with the primary end point (HR, 2.20 [1.10-4.41], P=0.02; and HR, 1.014 [1.006-1.078], P=0.02, respectively). Conclusions Mitral TEER is a safe and feasible intervention in selected patients with significant MAC and associated with similar mitral regurgitation reduction at 1 year compared with patients with none/mild MAC. Patients with moderate/severe MAC had a high 1-year mortality and less improvement in their symptoms after TEER.

Surgical Explantation of Failed Transcatheter Aortic Valve Replacement.

BACKGROUND: Recent reports have demonstrated worse than expected outcomes of surgical explantation after transcatheter aortic valve replacement (TAVR). However in-depth analysis of the short- and mid-term risk of concomitant cardiac surgery at the time of TAVR explant is lacking. METHODS: Data from the multicenter EXPLANT-TAVR registry of patients undergoing TAVR-explant between November 2009 and September 2020 were retrospectively analyzed. Patients undergoing concomitant procedures were included, but explants performed during the same admission as the initial TAVR or concomitant procedures performed on the aortic root, ascending aorta, or arch were excluded. Outcomes were evaluated between the isolated surgical aortic valve replacement (SAVR) and concomitant SAVR groups. Median follow-up was 6.6 months. RESULTS: Among 199 patients, concomitant SAVR was performed in 94 patients (47.2%), primarily with mitral valve surgery (n = 45) followed by coronary artery bypass grafting (n = 23). Despite similar mean ages between groups (72.8 vs 73.4 years), concomitant SAVR had a higher median Society of Thoracic Surgeons Predicted Risk of Mortality score at the index TAVR (5.9% vs 3.7%, P = .001). There were no differences in median time-to-explant between groups (12.9 vs 8.7 months, P = .78). However concomitant SAVR had longer mean cardiopulmonary bypass (166 vs 114 minutes, P = .001) and cross-clamp times (123 vs 81 minutes, P = .001). Both 30-day (16.7% vs 9.9%) and 1-year mortality (36.1% vs 22.1%) were higher with concomitant SAVR but did not reach statistical significance (both P > .05). On Kaplan-Meier analysis, actuarial estimates of cumulative survival were significantly lower with concomitant SAVR at 3 years (56.8% vs 81.1%, P = .020). CONCLUSIONS: For surgical explantation after TAVR failure, concomitant SAVR is associated with increased mortality. Further studies with longer follow-up are warranted to examine the benefit from earlier intervention before concomitant disease develops.

Impact of Mitral Regurgitation Etiology on Mitral Surgery After Transcatheter Edge-to-Edge Repair: From the CUTTING-EDGE Registry.

BACKGROUND: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown. OBJECTIVES: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology. METHODS: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery. RESULTS: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years. CONCLUSIONS: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes.

Aortic valve versus root surgery after failed transcatheter aortic valve replacement.

OBJECTIVE: We sought to determine outcomes of aortic valve replacement (AVR) versus root replacement after transcatheter AVR (TAVR) explantation because they remain unknown. METHODS: From November 2009 to September 2020, data from the EXPLANT-TAVR International Registry of patients who underwent TAVR explant were retrospectively reviewed, divided by AVR versus root replacement. After excluding explants performed during the same admission as the initial TAVR and concomitant procedures involving the other valves, 168 AVR cases were compared with 28 root replacements, and outcomes were reported at 30 days and 1 year. RESULTS: Among 196 patients (mean age, 73.5 ± 9.9 years) who had primary aortic valve intervention at TAVR explant, the median time from TAVR to surgical explant was 11.2 months (interquartile range, 4.4-32.9 months). Indications for explant were similar between the 2 groups. Compared with AVR, patients requiring root replacement had fewer comorbidities but more unfavorable anatomy for redo TAVR (52.6% vs 26.4%; P = .032), fewer urgent/emergency cases (32.1% vs 58.3%; P = .013), longer median interval from index TAVR to TAVR explant (17.6 vs 9.9 months; P = .047), and more concomitant ascending aortic replacement (58.8% vs 14.0%; P < .001). Median follow-up was 6.9 months (interquartile range, 1.4-21.6 months) after TAVR explant and 97.4% complete. Overall survival at follow-up was 81.2% with no differences between groups (log rank P = .54). In-hospital, 30-day, and 1-year mortality rates and stroke rates were not different between the 2 groups. CONCLUSIONS: In the EXPLANT-TAVR Registry, AVR and root replacement groups had different clinical characteristics, but no differences in short-term mortality and morbidities. Further investigations are necessary to identify patients at risk of root replacement in TAVR explant.

Impact of Tricuspid Regurgitation on Outcomes of Mitral Valve Surgery after Transcatheter Edge-to-Edge Repair.

Tricuspid regurgitation (TR) severity after mitral transcatheter edge-to-edge repair (TEER) has been shown to impact outcomes but unknown in patients requiring mitral valve (MV) surgery after TEER. We sought to determine the impact of preoperative TR severity and right ventricular (RV) dysfunction on MV surgery after TEER. From 7/2009 to 7/2020, 260/332 patients in the CUTTING-EDGE registry who underwent MV surgery after TEER had paired echocardiographic evaluation on TR severity, and ≥moderate (2+) vs <2+ TR at the time of index TEER were compared. Median follow-up post-MV surgery was 9.1 months, 96.5% complete at 30 days and 81.9% complete at 1 year. Mean age was 73.8 ± 10.3; with primary/mixed and secondary MR present in 65.6% and 32.0%, respectively. Proportion of ≥2+ TR increased from TEER to MV surgery (40% vs 57%, P < 0.001). Compared to <2+ TR group, ≥2+ pre-TEER TR patients were older, had higher STS risk score at TEER, higher RVSP, more RV dysfunction, more MR post-TEER, and a shorter median interval from TEER to MV surgery (1.9 vs 4.9 months, P = 0.023). Mortality was higher in the ≥2+ pre-TEER TR group at 30 days(24.2% vs 13.8%, P = 0.043) and 1 year (45.3% vs 22.3%, P = 0.003). On Kaplan-Meier analysis, cumulative mortality was 23.8% at 1 year and 31.6% at 3 years after MV surgery overall, and was associated with preoperative RV dysfunction (P = 0.023), ≥2+ TR at pre-TEER (P = 0.001) and presurgery (P = 0.004), but not concomitant tricuspid surgery. Moderate or greater pre-TEER TR was associated with worse outcomes, and pre-TEER TR worsened significantly at MV surgery. Concomitant tricuspid surgery did not increase overall mortality.

Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

BACKGROUND: Clopidogrel is the most frequently used P2Y12 inhibitor as a component of the dual antiplatelet regimen in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Prior studies have shown the variable efficacy of clopidogrel due to genotypic differences in the CYP2C19 enzyme function, which converts clopidogrel to its active metabolite. The aim of this meta-analysis is to evaluate the effectiveness of genotype testing-guided P2Y12 inhibitor prescription therapy to patients after PCI for ACS compared to non-genotype guided conventional treatment. METHODS: A comprehensive literature search was performed in PubMed, Embase, and Cochrane to identify relevant trials. Summary effects were calculated using a DerSimonian and Laird random-effects model as odds ratio with 95% confidence intervals for all the clinical endpoints. RESULTS: Seven studies with 9617 patients were included. Genotype-guided strategy arm included prasugrel or ticagrelor prescription to patients with loss of function (LOF) of CYP219 alleles (most commonly alleles being *2 and *3) and clopidogrel prescription to those without the LOF allele. The conventional arm included patients treated with clopidogrel without genotype testing. Comparison of genotype arm with conventional arm showed decreased major adverse cardiovascular events (MACE), improved cardiovascular (CV) mortality, and reduced incidence of myocardial infarction (MI) in the genotype arm, and a similar stroke incidence in the two arms. Regarding adverse events, the incidence of stent thrombosis was lower in the genotype arm than the conventional arm. CONCLUSION: Our analysis illustrates the possible advantages of genotype-guided P2Y12 inhibitor prescription strategy compared to non-genotype-guided strategy with reductions in MACE, CV mortality, MI, and stent thrombosis. This analysis can be used as a stepping stone to conducting further trials determining the efficacy of this treatment strategy in various ACS subtypes.

Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry.

OBJECTIVES: The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). BACKGROUND: Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking. METHODS: Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year. RESULTS: From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery. CONCLUSIONS: In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.

Surgical and Transcatheter Mitral Valve Replacement in Mitral Annular Calcification: A Systematic Review.

Mitral annular calcification with mitral valve disease is a challenging problem that could necessitate surgical mitral valve replacement (SMVR). Transcatheter mitral valve replacement (TMVR) is emerging as a feasible alternative in high-risk patients with appropriate anatomy. PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to December 25, 2019 for studies discussing SMVR or TMVR in patients with mitral annular calcification; 27 of 1539 articles were selected for final review. TMVR was used in 15 studies. Relevant data were available on 82 patients who underwent hybrid transatrial TMVR, and 354 patients who underwent transapical or transseptal TMVR. Outcomes on SMVR were generally reported as small case series (447 patients from 11 studies); however, 1 large study recently reported outcomes in 9551 patients. Patients who underwent TMVR had a shorter median follow-up of 9 to 12 months (range, in-hospital‒19 months) compared with patients with SMVR (54 months; range, in-hospital‒120 months). Overall, those undergoing TMVR were older and had higher Society of Thoracic Surgeons risk scores. SMVR showed a wide range of early (0%-27%; median 6.3%) and long-term mortality (0%-65%; median at 1 year, 15.8%; 5 years, 38.8%, 10 years, 62.4%). The median in-hospital, 30-day, and 1-year mortality rates were 16.7%, 22.7%, and 43%, respectively, for transseptal/transapical TMVR, and 9.5%, 20.0%, and 40%, respectively, for transatrial TMVR. Mitral annular calcification is a complex disease and TMVR, with a versatile option of transatrial approach in patients with challenging anatomy, offers a promising alternative to SMVR in high-risk patients. However, further studies are needed to improve technology, patient selection, operative expertise, and long-term outcomes.

Imaging the mitral valve: a primer for the interventional surgeon.

Transcatheter mitral valve interventions (TMVI) have evolved over the past decade as alternatives to open surgical repair for the therapeutic management of patients with severe mitral regurgitation (MR). Concurrent with the development of these technologies, quality multi-modality cardiac imaging has become essential in patient selection and procedural guidance. The former involves assessments of the pathophysiologic mechanisms of regurgitation, valvular anatomy and morphology, as well as objective quantification of the severity of MR. Both transthoracic and transesophageal echocardiography (TEE) are crucial and serve as the gateway to diagnosis and management of mitral valvular disease. Along with multi-detector computed tomography (CT) and cardiac magnetic resonance imaging (CMR), echocardiography plays an important role for preprocedural planning and evaluation of the spatial relationships of the mitral valvular complex with the coronary sinus, circumflex coronary artery and left ventricular (LV) outflow tract. Procedures that target mitral leaflets (e.g., MitraClip, PASCAL) or annulus (e.g., Cardioband, Carillon), or provide chordal (e.g., NeoChord, Harpoon) or valvular replacement, tend to be guided by TEE and assisted by fluoroscopy. As newer devices become available and outcomes of TMVI improve, cardiac imaging will undoubtedly continue to play an essential role in the success of percutaneous mitral valve repair (MVr) and replacement. The interventional surgeon of the future must therefore have a thorough understanding of the various imaging modalities while synthesizing and integrating novel concepts (e.g., neo-LV outflow tract) as applicable to assessing valvular function and pathology.

Surgical explantation of transcatheter aortic bioprosthesis: A systematic review and meta-analysis.

Background: Despite the rapid adoption of transcatheter aortic valve replacement (TAVR), aortic valve reintervention, particularly surgical TAVR valve explantation (TAVR explant), has not been well described. Methods: MEDLINE, Embase, and Web of Science were searched through July 2021 to identify observational studies and case series reporting clinical outcomes of TAVR explant. Data on the frequency of TAVR explant, patient demographic characteristics, clinical indications, operative data, and perioperative outcomes were extracted. Study-specific estimates were combined using one-group meta-analysis in a random-effects model. Results: A total of 10 studies were identified that included 1690 patients undergoing a TAVR explant. The frequency of TAVR explant among TAVR recipients was 0.4% (95% confidence interval [CI], 0.2%-0.6%). The mean patient age was 73.7 years (95% CI, 72.9-74.6 years). The mean Society of Thoracic Surgeons predicted risk of mortality was 5.9% (95% CI, 2.9%-8.8%) at the index TAVR and 8.1% (95% CI, 5.4%-10.8%) at TAVR explant. The mean time from implant to explant was 345.0 days (95% CI, 196.7-493.3 days). Among patients with documented device type, 59.8% (95% CI, 43.5%-76.0%) had a balloon-expandable valve and 40.2% (95% CI, 24.0%-56.5%) had a self-expandable valve. Concomitant procedures during TAVR explant were performed in 52.9% of patients (95% CI, 33.8%-72.0%), and the most common concomitant procedure was aortic repair (28.5%; 95% CI, 14.0%-42.9%). The 30-day mortality after TAVR explant was 16.7% (95% CI, 12.2%-21.2%). Conclusions: TAVR explant in patients with a failing TAVR appears to be rare; however, the clinical impact of TAVR explant is substantial. Implanters must be mindful of the need for a lifetime management strategy in younger and lower-risk patients when choosing the valve type for the initial procedure.

Valve-in-Valve Transcatheter Implantation Versus Redo Surgical Aortic Valve Replacement.

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) for a failing prosthesis is an appealing alternative to redo surgical AVR. We utilized data from the US National Inpatient Sample for the period 2012 to 2016 to identify hospitalizations for either ViV-TAVI or redo-SAVR. The primary outcomes of interest were in-hospital adverse events composite outcome (comprising of mortality, myocardial infarction, stroke, or acute kidney injury) and all-cause mortality. We used propensity score matching to adjust for the baseline differences between ViV-TAVI and redo-SAVR cohorts. Survey techniques were employed to compare the 2 groups. Over 5 years, there has been a considerable increase in both interventions for prosthetic aortic valve failure, with significantly higher utilization of ViV-TAVI compared to redo-SAVR (p <0.01). Out of the 3,305 hospitalizations for prosthetic aortic valve failure, 1,420 in matched pairs underwent either ViV-TAVI (n = 710) or redo-SAVR (n = 710). ViV-TAVI was associated with lower in-hospital composite adverse outcomes (14.1% vs 25.4%, p = 0.018), and numerically lower but statistically insignificant mortality (<1.0% vs 5.2%; p = 0.06). ViV-TAVI was associated with a decreased length of hospitalization (mean 6.6 vs 9.7 days; p <0.01). In the matched cohort, postoperative bleeding and transfusions were significantly lower for ViV-TAVI compared with redo-SAVR (17.6% vs 31.0% and 12% vs 31% respectively, p <0.01 for both). Acute kidney injury, sepsis, permanent pacemaker implantation, and vascular complications, although numerically better, did not differ between 2 strategies. In conclusion, ViV-TAVI is associated with lower in-hospital MACE rates and reduced length of hospitalization compared with redo-SAVR.

Trends and Outcomes With Transcatheter Versus Surgical Mitral Valve Repair in Patients ≥80 Years of Age.

Transcatheter mitral valve repair (TMVR) has shown comparable outcomes to surgical mitral valve replacement or repair (SMVR) in patients who are at a higher risk of surgical complications and therefore are not amenable to surgery. Elderly patients are considered poor surgical candidates due to their advanced age, and presence of comorbidities. A sub-analysis of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial identified patients of >70 years of age appear to have a similar risk-benefit profile for either approach of surgery or transcatheter. This finding does have some caveats considering the trial included surgical cohort with both repair and replacement. Utilizing the National Inpatient Sample, we identified a surgical cohort of ≥80 years of age that underwent mitral valve repair and used propensity matching to compare it with a similar cohort that underwent TMVR. In a well-balanced cohort, TMVR was associated with significantly lower in-patient mortality (0.7% vs 3.1%). TMVR was also associated with significantly decreased in-hospital complications such as acute kidney injury, cardiogenic shock, postoperative hemorrhage, transfusion, permanent pacemaker, and respiratory and vascular complications. Owing to this, the duration of hospital stay is approximately 6 days less with TMVR. Trend analysis has shown a paradigm shift in these elderly patients with 85% of all repairs in 2012 were performed surgically, whereas in 2016 almost 94% of all the repairs being performed via a transcatheter approach. In conclusion, in patients ≥80 years of age, the surgical MVR had 4-fold higher mortality compared to TMVR with higher cardiac, vascular, hemorrhagic and respiratory complications. Despite the limitations of being observational in nature, this data strongly supports the preferential use of the transcatheter approach for mitral valve repair in patients ≥80 years of age.