Repeat Mitral Valve Interventions After Transcatheter Edge-to-Edge Repair: The COAPT Trial.

The frequency and effectiveness of repeat mitral valve interventions (RMVI) after transcatheter edge-to-edge repair (TEER) for secondary mitral regurgitation (MR) are unknown. We aimed to examine the rate of and outcomes after RMVI after TEER in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial. Only 3.9% of COAPT trial patients required a repeat mitral valve intervention during 4-year follow-up which was successful in 90% of cases but was associated with an increased rate of heart failure (HF) hospitalizations (HFH). The COAPT trial randomized HF patients with severe secondary MR to TEER with the MitraClip device plus guideline-directed medical therapy (GDMT) versus GDMT alone. We evaluated the characteristics and outcomes of patients who had an RMVI during 4-year follow-up. A MitraClip implant was attempted in 293 patients randomized to TEER+GDMT, 10 of whom underwent an RMVI procedure (9 repeat TEER and 1 surgical mitral valve replacement) after 4 years of follow-up (cumulative incidence 3.90%, 95% confidence interval [CI] 2.08 to 7.08; median 182 days after the initial procedure). Patients with RMVI had larger mitral annular diameters, fewer clips implanted, and were more likely to have ≥3+MR at discharge compared with those without RMVI. Reasons for RMVI included failed index procedure because of difficult transseptal puncture (n = 2) or tamponade (n = 1); residual or recurrent severe MR after an initially successful procedure (n = 5); partial clip detachment (n = 1); and site-assessed mitral stenosis (n = 1). RMVI was successful in 8/10 (80%) patients. Patients who underwent RMVI had higher 4-year rates of HFH but similar mortality compared with those without RMVI. The annualized incidence rates of all HFH in patients who underwent RMVI were 234 events per 100 person-years (95% CI 139 to 395) pre-RMVI and 46 per 100 person-years (95% CI 25 to 86) post-RMVI as compared with 32 events per 100 patient-years (95% CI 28 to 36) in patients without RMVI. The rate ratio of HFH was reduced after RMVI in patients who underwent RMVI (0.20, 95% CI 0.09 to 0.45). In conclusion, the cumulative incidence of RMVI after 4 years was 3.9% in patients who underwent TEER for severe secondary MR in the COAPT trial. Patients who underwent RMVI were at increased risk of HFH which was reduced after the RMVI procedure. Clinical Trial Registration: Clinical Trial Name: Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) (COAPT) ClinicalTrial.gov Identifier: NCT01626079 URL:https://clinicaltrials.gov/ct2/show/NCT01626079.

Bioprosthetic valve fracture: a practical guide.

Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is currently indicated for the treatment of failed surgical tissue valves in patients determined to be at high surgical risk for re-operative surgical valve replacement. VIV TAVR, however, often results in suboptimal expansion of the transcatheter heart valve (THV) and can result in patient-prosthesis mismatch (PPM), particularly in small surgical valves. Bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR) can facilitate VIV TAVR by optimally expanding the THV and reducing the residual transvalvular gradient by utilizing a high-pressure inflation with a non-compliant balloon to either fracture or stretch the surgical valve ring, respectively. This article, along with the supplemental video, will provide patient selection, procedural planning and technical insights for performing BVF and BVR.

Adherence to Guideline-Recommended Therapy-Including Supervised Exercise Therapy Referral-Across Peripheral Artery Disease Specialty Clinics: Insights From the International PORTRAIT Registry.

Background Underuse of guideline-recommended therapy in peripheral artery disease (PAD) in administrative and procedural databases has been described, but reports on medically managed patients and referral to supervised exercise therapy (SET) in PAD are lacking. We aimed to document the use of PAD guideline-recommended therapy, including SET in patients with PAD symptoms consulting a specialty clinic across 3 countries. Methods and Results The 16-center PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry enrolled 1275 patients with new or an exacerbation of PAD symptoms (2011-2015). We prospectively documented antiplatelet medications, statins, smoking cessation counseling and/or therapy, and referral to SET: "2 quality measures" referred to the use of both statin and antiplatelet medications; "4 quality measures" to receiving all 4 measures. Median odds ratios were calculated to quantify treatment variation across sites. A total of 89% patients were on antiplatelets, 83% on statins, and 23% had been referred to SET. Of 455 current smokers, 342 (72%) patients received smoking cessation therapy/counseling. Overall, 77.2% of patients received "2 quality measures" and 19.7% "4 quality measures." The median odds ratio for 2 quality measures was 2.13 (95% CI, 1.61-3.56; P<0.001) and for 4 quality measures was 5.43 (95% CI, 2.84-17.91; P<0.001). Variability in adherence was not explained by country, except for referral to SET. The odds for SET referral in The Netherlands (70% referral rate) was nearly 100 times greater than in US sites (2% referral rate). Conclusions Not all patients who have undergone a PAD workup at a specialty care facility are treated with evidence-based care, especially so for SET.

Operator Experience and Outcomes of Transcatheter Mitral Valve Repair in the United States.

BACKGROUND: Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset. OBJECTIVES: The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr. METHODS: TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and >50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables. RESULTS: All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (≤1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p < 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p < 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases. CONCLUSIONS: For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR.

Association of Smoking Status With Long-Term Mortality and Health Status After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Background Smoking is a significant risk factor for aortic stenosis but its impact on clinical and health status outcomes after transcatheter aortic valve replacement (TAVR) has not been described. Methods and Results Patients (n=72 165) undergoing TAVR at 457 US sites in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between November 2011 and June 2016 were categorized at the time of TAVR as current/recent smokers versus prior/nonsmokers. A series of multivariable models examined the association between smoking status and outcomes, including 1-year mortality, rehospitalization, mean gradient, and health status (measured by the 12-item Kansas City Cardiomyopathy Questionnaire-Overall Summary Score [KCCQ-OS]) and in-hospital outcomes. A total of 4063 patients (5.6%) were smokers. Smokers presented for TAVR at a younger age (75 [68-81] years versus 83 [77-88] years) but with a greater burden of cardiovascular and lung disease. In adjusted models, smoking was associated with lower in-hospital mortality (relative risk, 0.74; 95% CI, 0.62-0.89 [P=0.001]) but not with in-hospital stroke/transient ischemic attack or myocardial infarction. Smoking status had no association with postdischarge mortality, stroke, myocardial infarction, or heart failure (HF) but was associated with slightly lower 1-year KCCQ-OS scores (2.4-point lower KCCQ-OS; 95% CI, -4.6 to -0.2 [P=0.031]) and higher mean aortic valve gradients (11.1 versus 10.2 mm Hg, P<0.001) in adjusted models. Conclusions The current/recent smoking rate in US patients with TAVR is 5.6% and smokers present at a younger age for TAVR. Smoking was associated with lower in-hospital but similar long-term survival after TAVR, slightly worse long-term health status, and marginally higher mean aortic valve gradients. Further research is needed to understand the effect of smoking cessation on outcomes.

Bioprosthetic valve fracture: Technical insights from a multicenter study.

OBJECTIVE: Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) can result in high residual gradients that are associated with increased mortality. Bioprosthetic valve fracture (BVF) has been shown to improve residual gradients following VIV TAVR; however, factors influencing the results of BVF have not been studied. METHODS: BVF was performed in 75 patients at 21 centers. Hierarchical multiple linear regression was performed to identify variables that were associated with lower final transvalvular gradient. RESULTS: Surgical valves with a median true internal diameter of 18.5 mm (interquartile range, 17.0-20.5 mm) were treated with VIV TAVR in conjunction with BVF using balloon-expandable (n = 43) or self-expanding (n = 32) transcatheter heart valves with a median size of 23 mm (interquartile range, 23-23 mm). There were no aortic root disruptions, coronary occlusions, or new pacemakers; in-hospital or 30-day mortality was 2.6% (2 out of 75). Final mean transvalvular gradient was 9.2 ± 6.3 mm Hg, but was significantly lower when BVF was performed after VIV TAVR compared with BVF first (8.1 ± 4.8 mm Hg vs 16.9 ± 10.1 mm Hg; P < .001). After adjusting for timing of BVF (ie, before or after VIV TAVR), transcatheter heart valve size/type, surgical valve mode of failure, true internal diameter, and baseline gradient and BVF balloon size, performing BVF after VIV TAVR (P < .001) and using a larger BVF balloon (P = .038) were the only independent predictors of lower final mean gradient. CONCLUSIONS: BVF can be performed safely and results in reduced residual transvalvular gradients. Performing BVF after VIV TAVR and using larger balloon appears to achieve the best hemodynamic results.

Is Bioprosthetic Valve Fracture Beneficial for Patients with Larger Surgical Valves Undergoing Valve in Valve TAVR?

PURPOSE OF REVIEW: This review aims to summarize data regarding bioprosthetic valve fracture (BVF), a novel technique that involves fracturing the surgical valve sewing ring to allow for further expansion of the transcatheter heart valve in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR). RECENT FINDINGS: Bench testing and clinical experience have demonstrated that most, but not all, bioprosthetic surgical valves can be fractured. BVF in patients with small- and intermediate-sized surgical valves results in a lower residual valve gradient and larger final valve effective orifice area as compared with standard VIV TAVR. However, whether patients with larger bioprothetic valves benefit from BVF, and whether the hemodynamic benefits of BVF translate into improved clinical outcomes, is unknown. BVF improves the hemodynamic results of VIV TAVR in small surgical valves. However, further research is needed to determine whether BVF is beneficial for patients with larger surgical valves, and whether the hemodynamic benefits of BVF result in improved clinical outcomes.

Bioprosthetic Valve Fracture to Facilitate Transcatheter Valve-in-Valve Implantation.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement is less effective in small surgical bioprostheses. We evaluated the feasibility of bioprosthetic valve fracture with a high-pressure balloon to facilitate valve-in-valve transcatheter aortic valve replacement. METHODS: In vitro bench testing on aortic tissue valves was performed on 19-mm and 21-mm Mitroflow (Sorin, Milan, Italy), Magna and Magna Ease (Edwards Lifesciences, Irvine, CA), Trifecta and Biocor Epic (St. Jude Medical, Minneapolis, MN), and Hancock II and Mosaic (Medtronic, Minneapolis, MN). High-pressure balloons Tru Dilation, Atlas Gold, and Dorado (C.R. Bard, Murray Hill, NJ) were used to determine which valves could be fractured and at what pressure fracture occurred. RESULTS: Mitroflow, Magna, Magna Ease, Mosaic, and Biocor Epic surgical valves were successfully fractured using high-pressures balloon 1 mm larger than the labeled valve size whereas Trifecta and Hancock II surgical valves could not be fractured. Only the internal valve frame was fractured, and the sewing cuff was never disrupted. Manufacturer's rated burst pressures for balloons were exceeded, with fracture pressures ranging from 8 to 24 atmospheres depending on the surgical valve. Testing further demonstrated that fracture facilitated the expansion of previously constrained, underexpanded transcatheter valves (both balloon and self-expanding) to the manufacturer's recommended size. CONCLUSIONS: Bench testing demonstrates that the frame of most, but not all, bioprosthetic surgical aortic valves can be fractured using high-pressure balloons. The safety of bioprosthetic valve fracture to optimize valve-in-valve transcatheter aortic valve replacement in small surgical valves requires further clinical investigation.