Prognostic Impact of Residual Moderate Mitral Regurgitation Following Valve-in-Valve Transcatheter Aortic Valve Implantation

ABSTRACT Introduction: The impact of mitral regurgitation (MR) on valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with failed bioprostheses remains unclear. The purpose of this study was to assess the prognostic impact of residual moderate MR following VIV-TAVI. Methods: We retrospectively analyzed 127 patients who underwent VIV-TAVI between March 2010 and November 2021. At least moderate MR was observed in 51.2% of patients before the procedure, and MR improved in 42.1% of all patients. Patients with postoperative severe MR, previous mitral valve intervention, and patients who died before postoperative echocardiography were excluded from further analyses. The remaining 114 subjects were divided into two groups according to the degree of postprocedural MR: none-mild MR (73.7%) or moderate MR (26.3%). Propensity score matching yielded 23 pairs for final comparison. Results: No significant differences were found between groups before and after matching in early results. In the matched cohort, survival probabilities at one, three, and five years were 95.7% vs. 87.0%, 85.0% vs. 64.5%, and 85.0% vs. 29.0% in the none-mild MR group vs. moderate MR-group, respectively (log-rank P=0.035). Among survivors, patients with moderate MR had worse functional status according to New York Heart Association (NYHA) class at follow-up (P=0.006). Conclusion: MR is common in patients with failed aortic bioprostheses, and improvement in MR-status was observed in over 40% of patients following VIV-TAVI. Residual moderate MR after VIV-TAVI is not associated with worse early outcomes, however, it was associated with increased mortality at five years of follow-up and worse NYHA class among survivors.

Prognostic Impact of Residual Moderate Mitral Regurgitation Following Valve-in-Valve Transcatheter Aortic Valve Implantation.

INTRODUCTION: The impact of mitral regurgitation (MR) on valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with failed bioprostheses remains unclear. The purpose of this study was to assess the prognostic impact of residual moderate MR following VIV-TAVI. METHODS: We retrospectively analyzed 127 patients who underwent VIV-TAVI between March 2010 and November 2021. At least moderate MR was observed in 51.2% of patients before the procedure, and MR improved in 42.1% of all patients. Patients with postoperative severe MR, previous mitral valve intervention, and patients who died before postoperative echocardiography were excluded from further analyses. The remaining 114 subjects were divided into two groups according to the degree of postprocedural MR: none-mild MR (73.7%) or moderate MR (26.3%). Propensity score matching yielded 23 pairs for final comparison. RESULTS: No significant differences were found between groups before and after matching in early results. In the matched cohort, survival probabilities at one, three, and five years were 95.7% vs. 87.0%, 85.0% vs. 64.5%, and 85.0% vs. 29.0% in the none-mild MR group vs. moderate MR-group, respectively (log-rank P=0.035). Among survivors, patients with moderate MR had worse functional status according to New York Heart Association (NYHA) class at follow-up (P=0.006). CONCLUSION: MR is common in patients with failed aortic bioprostheses, and improvement in MR-status was observed in over 40% of patients following VIV-TAVI. Residual moderate MR after VIV-TAVI is not associated with worse early outcomes, however, it was associated with increased mortality at five years of follow-up and worse NYHA class among survivors.

High Residual Gradient Following a Self-Expandable Transcatheter Aortic Valve-in-Valve Implantation — Risk Factor Analysis, Outcomes, and Survival

Abstract Introduction: Transcatheter aortic valve-in-valve implantation (TAVI-ViV) can be associated with unfavorable hemodynamic outcomes. This study aimed to estimate the prevalence, identify the risk factors, and evaluate the outcomes and survival of patients with high residual gradients after TAVI-ViV. Methods: A total of 85 patients were included in the study. The cohort was divided into group A, with postprocedural mean pressure gradient (PG) ≥ 20 mmHg, and group B, with mean PG < 20 mmHg. Results: Postprocedural PG ≥ 20 mmHg was observed in 24.7% of the patients. In a univariate analysis, preoperative gradient, pre-existing patient-prosthesis mismatch (PPM), deep valve implantation, small degenerated valves, and an older generation of transcatheter aortic valves were found to be risk factors for high residual gradient. Multivariate analysis showed that preexisting maxPG > 60 mmHg, implantation level of 4 mm below neo-annulus, and degenerated valve size ≤ 23 mm were independent predictors of high residual gradient. There were no differences in early morbidity (myocardial infarction, pacemaker implantation, stroke, acute renal insufficiency) between groups. Kaplan-Meier estimated that the survival rate was comparable at one and five years regardless of postoperative gradient. Survivors with high residual mean gradient were significantly affected by a high New York Heart Association (NYHA) class. Conclusion: High residual transvalvular gradient after TAVI-ViV is not rare, but it does not significantly affect mortality. High residual mean gradient has a negative impact on NYHA functional class improvement after the procedure. High preoperative gradient, implantation level, and small failed bioprosthesis may predispose to increased residual gradient.

High Residual Gradient Following a Self-Expandable Transcatheter Aortic Valve-in-Valve Implantation - Risk Factor Analysis, Outcomes, and Survival.

INTRODUCTION: Transcatheter aortic valve-in-valve implantation (TAVI-ViV) can be associated with unfavorable hemodynamic outcomes. This study aimed to estimate the prevalence, identify the risk factors, and evaluate the outcomes and survival of patients with high residual gradients after TAVI-ViV. METHODS: A total of 85 patients were included in the study. The cohort was divided into group A, with postprocedural mean pressure gradient (PG) ≥ 20 mmHg, and group B, with mean PG < 20 mmHg. RESULTS: Postprocedural PG ≥ 20 mmHg was observed in 24.7% of the patients. In a univariate analysis, preoperative gradient, pre-existing patient-prosthesis mismatch (PPM), deep valve implantation, small degenerated valves, and an older generation of transcatheter aortic valves were found to be risk factors for high residual gradient. Multivariate analysis showed that preexisting maxPG > 60 mmHg, implantation level of 4 mm below neo-annulus, and degenerated valve size ≤ 23 mm were independent predictors of high residual gradient. There were no differences in early morbidity (myocardial infarction, pacemaker implantation, stroke, acute renal insufficiency) between groups. Kaplan-Meier estimated that the survival rate was comparable at one and five years regardless of postoperative gradient. Survivors with high residual mean gradient were significantly affected by a high New York Heart Association (NYHA) class. CONCLUSION: High residual transvalvular gradient after TAVI-ViV is not rare, but it does not significantly affect mortality. High residual mean gradient has a negative impact on NYHA functional class improvement after the procedure. High preoperative gradient, implantation level, and small failed bioprosthesis may predispose to increased residual gradient.

Cardiac conduction abnormalities in patients with degenerated bioprostheses undergoing transcatheter aortic valve-in-valve implantations and their impact on long-term outcomes.

BACKGROUND: The relationship between preoperative cardiac conduction abnormalities (CCA) and long-term outcomes after transcatheter aortic valve-in-valve implantation (TAVI-VIV) remains unclear. The aim of the study was to evaluate the effects of preoperative CCA on mortality and morbidity after TAVI-VIV and to estimate the impact of new-onset CCA on postoperative outcomes. METHODS: Between 2011 and 2020, 201 patients with degenerated aortic bioprostheses were qualified for TAVI-VIV procedures in two German heart centers. Cases with previously implanted permanent rhythm-controlling devices were excluded (n = 53). A total of 148 subjects met the eligibility criteria and were divided into 2 study groups according to the presence of preexisting CCA (CCA (n = 84) and non-CCA (n = 64), respectively). Early and late mortality and morbidity were evaluated. Follow-up functional status was assessed according to New York Heart Association (NYHA) classification. RESULTS: There were no procedural deaths. TAVI-VIV related new-onset CCAs were observed in 35.8% patients. The 30-day permanent pacemaker implantation rate was 1.6% in non-CCA vs 9.5% in CCA group (p = 0.045). Preexisting right bundle-branch block (OR:5.01; 95%CI, 1.05-23.84) and first-degree atrioventricular block (OR:4.55; 95%CI, 1.10-18.73) were independent predictors of new pacemaker implantation. One-year and five-year probability of survival were comparable in CCA and non-CCA groups: 90.3% vs 91.8% and 68.2% vs 74.3%, respectively. Surviving patients with preexisting and new-onset CCA had a worse functional status according to NYHA classification at follow-up. CONCLUSION: Preexisting and new-onset postoperative CCAs did not affect early and late mortality after TAVI-VIV procedures, however, they may have a negative impact on late functional status.

Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device (from the Prospective VIVA Post Market Study).

Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate over time and therefore may necessitate a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve study, which evaluated transcatheter aortic valve implantation using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective Valve-in-Valve study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation, or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve transcatheter aortic valve implantation cases. Two-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality rate was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs 7.6%, p = 0.025). Discharge mean gradients ≥20 mm Hg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3 to 22.1]. In patients with failing surgical aortic bioprostheses, valve-in-valve treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of <20 mmHg can be achieved.

Outcome comparison of mitral valve surgery and MitraClip therapy in patients with severely reduced left ventricular dysfunction.

AIMS: The aim of this study was to compare the outcomes of surgical mitral valve repair or replacement (sMVR) and percutaneous edge-to-edge repair using MitraClip (pMVR) in patients with severe left ventricular dysfunction affected by functional mitral regurgitation (FMR). METHODS AND RESULTS: We retrospectively identified 132 patients with left ventricular ejection fraction (LVEF) â‰¦ 30% submitted to sMVR (n = 47) or pMVR (n = 85) for FMR at our centre from January 2013 to December 2017. To adjust for baseline imbalances, we used a propensity score matching by age, logistic EuroSCORE, and left ventricular end-systolic volume. After being matched, MitraClip therapy showed lower perioperative mortality and rate of complications yet increased residual mitral regurgitation (MR) grade than did surgery (0.2 ± 0.50 in sMVR vs. 1.3 ± 0.88 in pMVR, P < 0.0001). According to stratified multivariate Cox model analysis, residual MR severity was an independent risk factor for cardiac death [hazard ratio (HR), 2.81; 95% confidence interval [CI], 1.44-5.48, P = 0.0025] and re-hospitalization for heart failure (HR, 3.07; 95% CI, 1.50-6.29, P = 0.0022) at 1 year follow-up. Stratified multivariable Cox regression analysis at 3 years identified pMVR as risk factor for cardiac death (HR, 0.19; 95% CI, 0.040-0.86, P = 0.031) and re-hospitalization for heart failure (HR, 0.28; 95% CI, 0.077-0.99, P = 0.048). CONCLUSIONS: In patients with FMR and LVEF ≤ 30%, MitraClip therapy resulted in lower perioperative complications and mortality than sMVR. However, surgically treated patients who survived the perioperative stage had less residual MR and experienced lower rates of re-hospitalization for heart failure at 1 year and lower cardiac mortality at 1 and 3 years of follow-up than did patients undergoing pMVR.

Geriatric or cardiac rehabilitation? Predictors of treatment pathways in advanced age patients after transcatheter aortic valve implantation.

BACKGROUND: Aim of the study was to find predictors of allocating patients after transcatheter aortic valve implantation (TAVI) to geriatric (GR) or cardiac rehabilitation (CR) and describe this new patient group based on a differentiated characterization. METHODS: From 10/2013 to 07/2015, 344 patients with an elective TAVI were consecutively enrolled in this prospective multicentric cohort study. Before intervention, sociodemographic parameters, echocardiographic data, comorbidities, 6-min walk distance (6MWD), quality of life and frailty (score indexing activities of daily living [ADL], cognition, nutrition and mobility) were documented. Out of these, predictors for assignment to CR or GR after TAVI were identified using a multivariable regression model. RESULTS: After TAVI, 249 patients (80.7 ± 5.1 years, 59.0% female) underwent CR (n = 198) or GR (n = 51). GR patients were older, less physically active and more often had a level of care, peripheral artery disease as well as a lower left ventricular ejection fraction. The groups also varied in 6MWD. Furthermore, individual components of frailty revealed prognostic impact: higher values in instrumental ADL reduced the probability for referral to GR (OR:0.49, p <  0.001), while an impaired mobility was positively associated with referral to GR (OR:3.97, p = 0.046). Clinical parameters like stroke (OR:0.19 of GR, p = 0.038) and the EuroSCORE (OR:1.04 of GR, p = 0.026) were also predictive. CONCLUSION: Advanced age patients after TAVI referred to CR or GR differ in several parameters and seem to be different patient groups with specific needs, e.g. regarding activities of daily living and mobility. Thus, our data prove the eligibility of both CR and GR settings.

Femoral transcatheter valve-in-valve implantation as alternative strategy for failed aortic bioprostheses: A single-centre experience with long-term follow-up.

BACKGROUND: Surgical reoperation is still a standard procedure performed for degenerated aortic bioprostheses. On the other hand femoral minimally invasive valve-in-valve implantation (femTAVI-VIV) is an intriguing alternative. This clinical study was design to compare the early and late outcomes of redo-surgery (Redo-AVR) and femTAVI-VIV procedures for failed aortic bioprostheses. METHODS: We retrospectively reviewed 108 patients with degenerated aortic bioprostheses qualified for isolated Redo-AVR (n = 40) or femTAVI-VIV (n = 68) between 2003 and 2018. Both cohorts were divided into intermediate and high-risk groups according to the EuroSCORE II (4-9% and >9%). Propensity score matching selected 20 pairs in Intermediate-risk group and 10 pairs in High-risk group for the final comparison. RESULTS: Patients qualified for femTAVI-VIV were older (79.2 vs 72.9 years, p < 0.001) and at higher risk (EuroSCORE II 10.9 vs 7.8%, p = 0.005) than Redo-AVR subjects. Overall survival in femTAVI-VIV and Redo-AVR was comparable at 30-days, 1- and 5-years, respectively (92.6% vs 92.5%, 85.2% vs 85.0% and 62.9% vs 72.5%, p = 0.287). After PSM no differences in mortality, myocardial infarction, pacemaker implantation, stroke or acute renal insufficiency were found. Transcatheter procedure was associated with shorter hospital stay, lower rate of blood products transfusions and higher incidence of mild paravalvular leaks. CONCLUSION: Our study supports the opinion that transcatheter approach for treatment of patients with degenerated aortic bioprostheses is a safe alternative to Redo-AVR procedures particularly for those at high-risk.

TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device: 1-Year Results From the Prospective VIVA Postmarket Study.

OBJECTIVES: The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation. BACKGROUND: Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery. METHODS: VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve. RESULTS: Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later. CONCLUSIONS: Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298).

Surgical revision of failed percutaneous edge-to-edge mitral valve repair: lessons learned.

OBJECTIVES: Although percutaneous edge-to-edge mitral valve repair with the MitraClip system is becoming widely adopted in clinical practice, surgical experience on how to correct failed MitraClip therapy is limited. We aimed to analyse the surgical and pathological outcomes after surgical revision of the failed MitraClip therapy. METHODS: Between January 2011 and January 2018, 25 patients (age 73 ± 9 years; men 48%; New York Heart Association class 3.4 ± 0.49) were admitted for severe mitral regurgitation at a median of 54 days (range 1-1496 days) after MitraClip edge-to-edge repair. Perioperative variables were analysed for their association with surgical outcomes. RESULTS: All patients underwent explantation of the MitraClip system and subsequent mitral valve replacement. Perioperative mortality was as high as 28%, mainly due to pre-existing cardiogenic or septic shock. The Kaplan-Meier analysis revealed a 53% overall 1-year survival. Among preoperative variables, the logistic European System for Cardiac Operative Risk Evaluation score, left ventricular ejection fraction and liver dysfunction had a significant influence on in-hospital survival. Intraoperatively, the predominant pathology included mitral valve leaflet damage due to tear, degeneration or infection. Although leaflet tears or MitraClip detachment mainly occurred within the first 6 months after MitraClip therapy, leaflet infections and degeneration mainly occurred later during follow-up. CONCLUSIONS: The surgical revision of failed MitraClip therapy is feasible but has high perioperative mortality, especially among patients with cardiogenic shock, septic shock or liver failure. Mitral regurgitation after the MitraClip therapy is mainly caused by mitral valve leaflet damage due to tear, degeneration or infection, all related to the MitraClip itself.

Severe structural deterioration of small aortic bioprostheses treated with valve-in-valve transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to evaluate outcomes of valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with degenerated small bioprostheses. METHODS: Outcomes of consecutive 27 high-risk patients (logistic EuroSCORE 35.5 ± 18.5%) with a mean age of 81.0 ± 5.9 years who underwent VIV-TAVI for degenerated small bioprostheses (19 mm-11.1%; 20 mm-11.1%; 21 mm-77.8%) were analyzed. Medtronic CoreValve (n = 11) or CoreValve Evolut-R prostheses (n = 16) were implanted. Follow-up was 3.2 ± 2.0 years. RESULTS: Early mortality was 11.1%. One patient died intraoperatively due to left ventricle perforation, two others during the in-hospital period as a result of sudden cardiac death and pulmonary embolism. VIV-TAVI was completed in 26 cases (96.3%-success rate). Two patients required pacemaker implantation. Acute kidney injury occurred in two other patients. At discharge, mean transvalvular gradient was 19.2 ± 9.5 mmHg and in 25.9% of patients mean gradient exceeded 20 mmHg. Overall mortality was 25.9% and mortality from cardiac or unknown causes at 18.5%. Ninety percent of survivors were in New York Heart Association (NYHA) class I or II. CONCLUSIONS: Transfemoral VIV-TAVI in patients with small, degenerated bioprostheses appears to be a promising alternative to surgery. Although the vast majority of patients have significant improvement in their NYHA class, the rate of persistent, residual gradients is relatively high and will need to be followed closely with serial echocardiograms.

Nutrition and mobility predict all-cause mortality in patients 12 months after transcatheter aortic valve implantation.

BACKGROUND: The aim of the study was to determine pre-interventional predictors for all-cause mortality in patients after transcatheter aortic valve implantation (TAVI) with a 12-month follow-up. METHODS: From 10/2013 to 07/2015, 344 patients (80.9 ± 5.0 years, 44.5% male) with an elective TAVI were consecutively enrolled prospectively in a multicentre cohort study. Prior to the intervention, sociodemographic parameters, echocardiographic data and comorbidities were documented. All patients performed a 6-min walk test, Short Form 12 and a Frailty Index (score consisting of activities of daily living, cognition, nutrition and mobility). Peri-interventional complications were documented. Vital status was assessed over telephone 12 months after TAVI. Predictors for all-cause mortality were identified using a multivariate regression model. RESULTS: At discharge, 333 patients were alive (in-hospital mortality 3.2%; n = 11). During a follow-up of 381.0 ± 41.9 days, 46 patients (13.8%) died. The non-survivors were older (82.3 ± 5.0 vs. 80.6 ± 5.1 years; p = 0.035), had a higher number of comorbidities (2.6 ± 1.3 vs. 2.1 ± 1.3; p = 0.026) and a lower left ventricular ejection fraction (51.0 ± 13.6 vs. 54.6 ± 10.6%; p = 0.048). Additionally, more suffered from diabetes mellitus (60.9 vs. 44.6%; p = 0.040). While the global Frailty Index had no predictive power, its individual components, particularly nutrition (OR 0.83 per 1 pt., CI 0.72-0.95; p = 0.006) and mobility (OR 5.12, CI 1.64-16.01; p = 0.005) had a prognostic impact. Likewise, diabetes mellitus (OR 2.18, CI 1.10-4.32; p = 0.026) and EuroSCORE (OR 1.21 per 5%, CI 1.07-1.36; p = 0.002) were associated with a higher risk of all-cause mortality. CONCLUSIONS: Besides EuroSCORE and diabetes mellitus, nutrition status and mobility of patients scheduled for TAVI offer prognostic information for 1-year all-cause mortality and should be advocated in the creation of contemporary TAVI risk scores.

Multicomponent cardiac rehabilitation in patients after transcatheter aortic valve implantation: Predictors of functional and psychocognitive recovery.

Background In the last decade, transcatheter aortic valve implantation has become a promising treatment modality for patients with aortic stenosis and a high surgical risk. Little is known about influencing factors of function and quality of life during multicomponent cardiac rehabilitation. Methods From October 2013 to July 2015, patients with elective transcatheter aortic valve implantation and a subsequent inpatient cardiac rehabilitation were enrolled in the prospective cohort multicentre study. Frailty-Index (including cognition, nutrition, autonomy and mobility), Short Form-12 (SF-12), six-minute walk distance (6MWD) and maximum work load in bicycle ergometry were performed at admission and discharge of cardiac rehabilitation. The relation between patient characteristics and improvements in 6MWD, maximum work load or SF-12 scales were studied univariately and multivariately using regression models. Results One hundred and thirty-six patients (80.6 ± 5.0 years, 47.8% male) were enrolled. 6MWD and maximum work load increased by 56.3 ± 65.3 m ( p < 0.001) and 8.0 ± 14.9 watts ( p < 0.001), respectively. An improvement in SF-12 (physical 2.5 ± 8.7, p = 0.001, mental 3.4 ± 10.2, p = 0.003) could be observed. In multivariate analysis, age and higher education were significantly associated with a reduced 6MWD, whereas cognition and obesity showed a positive predictive value. Higher cognition, nutrition and autonomy positively influenced the physical scale of SF-12. Additionally, the baseline values of SF-12 had an inverse impact on the change during cardiac rehabilitation. Conclusions Cardiac rehabilitation can improve functional capacity as well as quality of life and reduce frailty in patients after transcatheter aortic valve implantation. An individually tailored therapy with special consideration of cognition and nutrition is needed to maintain autonomy and empower octogenarians in coping with challenges of everyday life.

Transcatheter aortic valve implantation in patients with low-flow, low-gradient aortic stenosis.

OBJECTIVES: The purpose of this study was to evaluate the efficacy and outcome of transcatheter aortic valve implantation (TAVI) in patients with low-flow, low-gradient aortic stenosis (LG-AS). BACKGROUND: Patients with LG-AS have a poor prognosis with medical treatment and a high risk for surgical aortic valve replacement. METHODS: Between January 2009 and June 2010, a total of 1,302 patients underwent TAVI for severe AS and were prospectively included in the multicenter German TAVI registry. RESULTS: LG-AS was present in 149 patients (11.4%; mean age: 80.2 ± 6.3 years). In this subgroup, the EuroSCORE was significantly higher (26.8 ± 16.6 vs. 20.0 ± 13.3; p < 0.0001) compared with patients with high-gradient AS (HG-AS). The procedural success rate (LG-AS: 95.3% vs. HG-AS: 97.5%; p = 0.13) and the rate of TAVI-associated complications were comparable in both groups (new pacemaker: 27.0% vs. 28.1%; p = 0.76; cerebrovascular events: 3.4% vs. 3.1%, p = 0.83). However, post-operative low-output syndrome occurred more frequently in the LG-AS-group (LG-AS: 14.9% vs. HG-AS: 5.7%, p < 0.0001), and mortality at 30 days and 1 year was significantly higher in this subgroup (LG-AS: 12.8% and 36.9% vs. HG-AS: 7.4% and 18.1%; p < 0.001 and p < 0.0001, respectively). Post-operative New York Heart Association functional class improved, and self-assessed quality of life increased significantly, demonstrating a substantial benefit in the LG-AS group at 30 days and 1 year after TAVI. CONCLUSIONS: In high-risk patients with LG-AS, TAVI is associated with a significantly higher mortality at 30 days and at 1 year. However, long-term survivors benefit from TAVI with functional improvement and a significantly increased quality of life. Therefore, in view of the poor prognosis with medical treatment, TAVI should be considered an option in high-risk patients with LG-AS.