Prohibitive Surgical Risk Patients Research Articles

Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

BackgroundThe CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). ObjectivesThis study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. MethodsAn independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. ResultsIn 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). ConclusionsThe study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833)

1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients

BackgroundFavorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. ObjectivesThe authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. MethodsPatients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. ResultsNinety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). ConclusionsAt 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

BackgroundSevere symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging. ObjectivesThe CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial. MethodsPatients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months. ResultsA prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge]). ConclusionsThe CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.

Transcatheter Aortic Valve Replacement in High-Risk Surgical Patient with Severe Aortic Insufficiency

Background: Transcatheter aortic valve replacement (TAVR) is approved by the FDA for severe aortic stenosis (AS) in patients of all surgical risk categories but has yet to be studied for its utility in aortic insufficiency (AI), despite the need for a safe alternative to surgery for prohibitive surgical risk patients. Case Report: We describe a case of a female patient who presented with acute decompensated congestive heart failure (CHF) with New York Heart Association (NYHA) Class IV symptoms. She was found to have severe AI leading to acute decompensation. Two years prior to this, she had aortic valve endocarditis that had potentially resulted in severe AI. Considering her underling comorbidities including diabetes mellitus, hypertension, morbid obesity and multiple myeloma on active chemotherapy at the time of evaluation, the patient was a high-risk surgical candidate for surgical aortic valve repair (SAVR) in view of elevated risk of mortality, infection, and poor wound healing. After critical and comprehensive assessment, transcatheter aortic valve intervention was considered to be an appropriate choice of treatment. TAVR was successfully performed that resulted in immediate improvement of aortic valve function. On subsequent follow-ups, she demonstrated markedly improved symptoms and reduced status to NYHA Class II HF symptoms. Conclusion: TAVR is a potential treatment modality for patients with severe AI who are poor surgical candidates for SAVR. We hope our case contributes to the growing pool of studies investigating the utility of TAVR procedure in patients with severe AI.

Mitral Regurgitation in the High-Risk Patient: Integrating an Expanding Armamentarium of Transcatheter Devices Into the Treatment Algorithm.

Over the last decade, multiple transcatheter mitral valve repair and replacement strategies have emerged, yet there is only 1 US Food and Drug Administration approved device, the MitraClip (Abbott Vascular, Inc., Santa Clara, CA). Current guidelines support the use of the MitraClip in high or prohibitive surgical risk patients, but there are many patients that are not anatomically suited for the device. This review article discusses the approach to degenerative and functional mitral regurgitation in the high-prohibitive risk patient, how to choose transcatheter treatment options (both approved and investigational), and potential management for therapy failure.

Percutaneous “edge-to-edge” leaflet repair in patient with primary mitral valve regurgitation

Mitral regurgitation (MR) is the most common left-sided heart valve disease in developed countries with a constantly rising number of patients requiring hospitalization or intervention. Organic MR is defined as a primary structural abnormality of the mitral valve (MV) apparatus which may be caused by a broad set of pathological processes, among which myxomatous degeneration of the leaflets causing MV prolapse is the most common. If left untreated, chronic severe MR leads to serious adverse outcomes, from heart failure to death, but medical therapy is unable to change the natural history of the disease. Surgical correction, by means of valve repair or replacement, is the gold standard for the treatment of symptomatic patients with severe primary MR. However, surgery is not feasible for a large percentage of patients because of old age, reduced left ventricular ejection fraction and the presence of severe comorbidities. Therefore, in recent years, several percutaneous therapeutic alternatives suitable for high or prohibitive surgical risk patients were developed. In this review we discuss the transcatheter treatment of primary MR, from available evidence to technical practice, with a focus on the percutaneous “edge-to-edge” leaflet repair performed with the MitraClip System and the PASCAL Repair System.

P1798 Determinants of increased mitral mean diastolic gradient after transcatheter edge-to-edge mitral valve repair

Abstract Background Transcatheter edge-to-edge mitral valve repair (TMVR; MitraClip, Abbott Vascular) is clinically approved for treatment of severe, symptomatic mitral regurgitation (MR) in high or prohibitive surgical risk patients. Iatrogenic mitral stenosis is a known complication of TMVR, but determinants of increased post-procedure mean diastolic gradient are not well defined. Purpose We aimed to investigate the determinants of increased mitral mean diastolic gradient after TMVR. Methods We retrospectively reviewed 59 patients. 2D and 3D TEE data sets acquired before and immediately after procedure were analyzed. 4D Cardio-View and 4D MV-Assessment (TomTec, Germany) were used for the analysis of the 3D volume data set. Quantitative mitral valve analysis was done at the end of systole. Increased mitral mean diastolic gradient after TMVR was correlated with pre-procedure 2D and 3D echocardiographic data. Results 34 patients had primary MR, 25 patients had mixed/secondary MR. Baseline mean mitral diastolic gradient was 2.0 ± 0.9mmHg and increased to 3.9 ± 1.8mmHg post-TMVR and the mean 3D planimetric mitral valve area decreased from 5.3 ± 1.5cm2 to 2.6 ± 1.0cm2. Implantation of multiple clips was performed less frequently in patients with smaller baseline mitral valve area; 8% vs 47% in the lowest quartile vs all others (p = 0.006). 12(20%) of patients had a mean diastolic gradient &amp;gt;5mmHg post-TMVR and 15(25%) of patients had a post-TMVR mitral valve area &amp;lt;2.0 cm2. There was no significant difference in post-procedure heart rate between patients with mean diastolic gradient ≤5mmHg vs &amp;gt;5mmHg (p = 0.08). Patient characteristics according to post-TMVR mean diastolic gradient are shown in the Table. Post-TMVR mean diastolic gradient &amp;gt;5mmHg was more common in patients with increased pre-procedure mean diastolic gradient(p = 0.006), post-TMVR mitral valve area &amp;lt;2.0 cm2(40% vs 14%, p = 0.03), and ≥moderate residual mitral regurgitation(38% vs 11%, p = 0.02). Post-TMVR mitral valve area &amp;lt;2.0cm2 was present in 50% vs 19% of patients with vs without a mean gradient &amp;gt;5mmHg(p = 0.04). Conclusions Elevated post-TMVR mean diastolic gradient is multifactorial and related to mitral stenosis, but residual mitral regurgitation also appears to be an important contributor to increased gradients in some patients. Larger cohorts are likely needed to assess the concurrent impact of mitral annular calcification, leaflet calcification, and other variables on post-TMVR mean gradient. Abstract P1798 Figure. 2D and 3D Echocardiographic Parameters

The Prognostic Impact of the Geriatric Nutritional Risk Index in Patients with Severe Aortic Stenosis who Undergo Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) is increasingly being utilized for treatment of severe aortic stenosis (AS) in intermediate, high, and prohibitive surgical-risk patients. 1 Although T...

Transcatheter Mitral Valve Interventions: Current Therapies and Future Directions.

Transcatheter interventions for the treatment of aortic valve stenosis have become commonplace since the advent of transcatheter aortic valve implantation. However, transcatheter mitral valve therapies have lagged in development due to the complexity of mitral valve anatomy. Transcatheter edge-to-edge leaflet repair using the MitraClip device provides an option for the treatment of severe primary mitral valve regurgitation in high or prohibitive surgical risk patients, and multiple novel approaches are evolving to replace or repair the mitral valve. Devices for the treatment of calcific mitral stenosis, primary mitral regurgitation, and functional mitral regurgitation have been developed and are currently either being evaluated in clinical trials or are in earlier stages of preclinical development. We are optimistic that our armamentarium will soon expand to include a myriad of transcatheter interventions for mitral valve disease.

The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland.

IntroductionFew studies have assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008, and data on current TAVI activity or practice are missing.AimTo assess the dynamics of TAVI adoption in Poland and to detect differences among Polish centres in TAVI practice and decision-making.Material and methodsThe Polish Interventional Cardiology TAVI Survey (PICTS) was approved by the Polish Association of Cardiovascular Interventions and presented to all 21 national TAVI centres. Between 2008 and 2015 the cumulative number of TAVI performed in Poland was 2189. The annual number of TAVI rose from 8 in 2008 to 670 in 2015 (0.21 to 17.4 implants per million inhabitants, respectively).ResultsThe median TAVI experience per centre was 80 procedures (95% CI: 38.1–154.6). In 2015 the TAVI penetration rate reached 5.12% of the estimated eligible Polish population. Inoperable and high-risk patients are treated with TAVI in all centres, with 52% of Heart Teams also qualifying medium-risk patients. The rate of transfemoral implantations increased to 83.2% of all procedures in 2015, while transapical implantations decreased to 12%. The frequency of subclavian, direct aortic or transcarotid routes in 2015 was below 3% each.ConclusionsThe PICTS survey observed a positive but slow rate of adoption of TAVI in Poland. When compared to Western European countries, our findings highlight a significant treatment gap in high or prohibitive surgical risk patients with severe aortic stenosis. Remarkable variations in TAVI practices among Polish TAVI centres warrant publication of joint national guidelines and recommendations.

Improved Functional Status and Quality of Life in Prohibitive Surgical Risk Patients With Degenerative Mitral Regurgitation After Transcatheter Mitral Valve Repair

BackgroundSurgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-risk DMR patients have not been previously reported. ObjectivesThis study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive surgical risk undergoing TMVR. MethodsA prohibitive-risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies. ResultsA total of 141 high-risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive surgical risk (STS score: 13.2 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 ± 40.1 ml to 108.5 ± 37.9 ml; p < 0.0001 [n = 69 survivors with paired data]). SF-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced. ConclusionsTMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. (Real World Expanded Multi-center Study of the MitraClip System [REALISM]; NCT01931956)

Transcatheter Aortic Valve Replacement in Europe: Adoption Trends and Factors Influencing Device Utilization

The authors sought to examine the adoption of transcatheter aortic valve replacement (TAVR) in Western Europe and investigate factors that may influence the heterogeneous use of this therapy. Since its commercialization in 2007, the number of TAVR procedures has grown exponentially. The adoption of TAVR was investigated in 11 European countries: Germany, France, Italy, United Kingdom, Spain, the Netherlands, Switzerland, Belgium, Portugal, Denmark, and Ireland. Data were collected from 2 sources: 1) lead physicians submitted nation-specific registry data; and 2) an implantation-based TAVR market tracker. Economic indexes such as healthcare expenditure per capita, sources of healthcare funding, and reimbursement strategies were correlated to TAVR use. Furthermore, we assessed the extent to which TAVR has penetrated its potential patient population. Between 2007 and 2011, 34,317 patients underwent TAVR. Considerable variation in TAVR use existed across nations. In 2011, the number of TAVR implants per million individuals ranged from 6.1 in Portugal to 88.7 in Germany (33 ± 25). The annual number of TAVR implants performed per center across nations also varied widely (range 10 to 89). The weighted average TAVR penetration rate was low: 17.9%. Significant correlation was found between TAVR use and healthcare spending per capita (r = 0.80; p = 0.005). TAVR-specific reimbursement systems were associated with higher TAVR use than restricted systems (698 ± 232 vs. 213 ± 112 implants/million individuals ≥ 75 years; p = 0.002). The authors' findings indicate that TAVR is underutilized in high and prohibitive surgical risk patients with severe aortic stenosis. National economic indexes and reimbursement strategies are closely linked with TAVR use and help explain the inequitable adoption of this therapy.

Transcatheter aortic valve implantation in Jehovah's Witness patients with symptomatic severe aortic valve stenosis

Transcatheter aortic valve implantation (TAVI) is currently reserved for high or prohibitive surgical-risk patients with aortic valve stenosis. We report on successful TAVI in two Jehovah's witness patients. It offers a simple and effective treatment of severe aortic valve stenosis in high-risk patients who refuse the use of allogeneic blood and blood products.

PMD45 Optar Study: Transcatheter Aortic Valve Implantation (TAVI) versus Optimal Medical Treatment (OMT) in prohibitive Surgical Risk Patients with Severe Aortic Stenosis (AS) – An Exploratory Cost-Effectiveness Analysis

PMD45 Optar Study: Transcatheter Aortic Valve Implantation (TAVI) versus Optimal Medical Treatment (OMT) in prohibitive Surgical Risk Patients with Severe Aortic Stenosis (AS) – An Exploratory Cost-Effectiveness Analysis