Balloon-expandable transcatheter heart valves for treatment of aortic valve stenosis in patients with large aortic annuli: Evaluation of deployment balloon overfilling strategies.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using balloon-expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients. METHODS: Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-3 definitions. RESULTS: Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (˂750 mm³) even in aortic annuli of 29.0-30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750-3200 mm³). Accordingly, a low calcification group (˂750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p ˂ 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All-cause 30-day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented. CONCLUSION: Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex ˂750 mm³.

Valve-in-valve procedures for degenerated surgical and transcatheter aortic valve bioprostheses using a latest-generation self-expanding intra-annular transcatheter heart valve.

Background: Valve-in-valve (ViV) transfemoral transcatheter aortic valve implantation (TAVI) for failing aortic surgical bioprostheses or transcatheter heart valves (THV) has demonstrated a reasonable clinical and hemodynamic efficacy. Traditionally, self-expanding (SE) supra-annular THV are considered to result in superior hemodynamics compared with balloon-expandable intra-annular THV after ViV. However, so far no data are found on latest-generation intra-annular SE THV for aortic ViV procedures which might be superior with regard to coronary access or subsequent valve reintervention. Aim: We herein aim to evaluate a latest-generation SE intra-annular THV for aortic ViV procedures. Materials and methods: Between May 2022 and November 2022, five consecutive patients (4/5 female with mean age of 76.2 years and mean Society of Thoracic Surgeons predicted risk of mortality score of 2.9%) received ViV TAVI using the Navitor system (Abbott, Chicago, IL, USA) for treatment of failing surgical bioprostheses or THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium 3 (VARC-3) definitions. Results: At 30 days, absence of mortality and VARC-3 adjudicated clinical endpoints were documented. Echocardiography at 30 days revealed complete absence of paravalvular leakage and single-digit mean transvalvular gradients (mean of 6.0 mmHg) in all patients. Conclusion: The investigated intra-annular SE THV results in excellent 30-day outcomes for aortic ViV procedures for failing surgical bioprostheses or THV. Despite the intra-annular design, hemodynamic results were excellent, even in small bioprostheses. Ease of use of this valve platform is reflected by only two cycles of resheathing in five ViV procedures with hemodynamic stability during all steps of valve deployment.

Contemporary Outcome Trends in Transcatheter Aortic Valve-in-Valve Implantation Versus Redo Aortic Valve Replacement.

As valve-in-valve (ViV) transcatheter aortic valve implantation is still an evolving method, we evaluated the development of early and midterm outcomes after ViV and conventional redo-surgical aortic valve replacement (SAVR) over the past 2 decades. In-hospital databases were retrospectively screened for patients ≥60 years treated for failing bioprosthetic aortic valves at our center. Clinical and follow-up characteristics were compared between patients who underwent ViV or redo-SAVR according to valve academic research consortium-2 (VARC-2) definitions. The comparison of outcome parameters was adjusted for baseline differences between groups. Between June 2002 and April 2020, 209 patients with ViV and 65 redo-SAVR patients met inclusion criteria. No significant differences were found in 30 days (ViV 3.8%, SAVR 3.1%, p = 0.778) or 6-month mortality (ViV 14.0%, SAVR 7.5%, p = 0.283). As patients with ViV less frequently experienced acute kidney injury (stage II or III) and life-threatening bleeding, they more frequently reached the 30-day VARC-2 combined safety end point (79.2% vs 61.5%, odds ratio [OR] 2.540, p = 0.023). Patients with ViV less frequently reached clinical efficacy (68.3% vs 84.6%, OR 0.408, p = 0.041) and device success (79.9% vs 92.3%, OR 0.311, p = 0.040) end points, because of higher frequency of postprocedural transvalvular gradients >20 mm Hg. However, over the past decade, VARC-2 clinical efficacy and device success rates continuously increased in ViV cases. In conclusion, ViV and SAVR were associated with similar acute mortality and different beneficial and adverse outcome profiles in this single-center cohort. Results after ViV procedures have continuously improved over the past years.

Impact of left ventricular outflow tract calcification in patients undergoing transfemoral transcatheter aortic valve implantation.

BACKGROUND: Left ventricular outflow tract (LVOT) calcification is known to be associated with adverse outcomes after transcatheter aortic valve implantation (TAVI) in patients receiving first-generation transcatheter heart valves (THV). AIMS: The aim of the present study was to assess the prevalence of LVOT calcification as well as its impact on outcomes in a contemporary TAVI patient cohort. METHODS: This retrospective single-centre analysis includes 1,207 patients who underwent transfemoral TAVI between 2012 and 2018 and in whom adequate contrast-enhanced multislice computed tomgraphy (MSCT) imaging for quantification of LVOT calcification was available. RESULTS: Significant LVOT calcification, defined as >10 mm3, was present in 37.4% (n=451) of the patient cohort. After applying propensity score matching there was no difference between patients without (w/o; n=358) and with (w; n=358) significant LVOT calcification with respect to baseline clinical characteristics. At 30 days, the composite of all-cause mortality and non-disabling/disabling stroke occurred more often in patients w LVOT calcification compared to those w/o (4.6 vs 10.1%, p=0.008). Moreover, the composite VARC-3 endpoint of device success at 30 days was in favour of patients w/o LVOT calcification (82.2% vs 73.4%, p=0.007). According to Kaplan-Meier analysis, all-cause mortality one year after TAVI was higher in patients w vs w/o LVOT calcification (12.9 vs 21.4 %, p=0.004). CONCLUSIONS: In patients undergoing TAVI, the presence of significant LVOT calcification is common and associated with worse short-term clinical and functional outcomes as well as higher one-year mortality rates compared to patients w/o LVOT calcification.

End-stage renal disease, calcification patterns and clinical outcomes after TAVI.

BACKGROUND: Patients with chronic hemodialysis due to end-stage renal disease (ESRD) or severely impaired kidney function (CKD) constitute a relevant share of patients undergoing trans-catheter aortic valve implantation (TAVI). However, data on specific challenges and outcomes remain limited. AIM: We aimed to characterize this patient population, evaluate clinical results and assess the significance of calcification patterns. METHODS: This retrospective single-center analysis evaluated 2,712 TAVI procedures (2012-2019) according to baseline renal function: GFR < 30 ml/min/1.73m2 (CKD; n = 210), chronic hemodialysis (ESRD; n = 119) and control (CTRL; n = 2383). Valvular and vascular calcification patterns were assessed from contrast-enhanced multi-detector computed tomography. Outcomes were evaluated in accordance with the VARC-2 definitions. RESULTS: Operative risk was higher in ESRD and CKD vs. CTRL (STS-score 8.4% and 7.6% vs. 3.9%, p < 0.001) and patients with ESRD had more severe vascular calcifications (49.1% vs. 33.9% and 29.0%, p < 0.01). Immediate procedural results were similar but non-procedure-related major/life-threatening bleeding was higher in ESRD and CKD (5.0% and 5.3% vs. 1.6%, p < 0.01). 3-year survival was impaired in patients with ESRD and CKD (33.3% and 35.3% vs. 65.4%, p < 0.001). Multivariable analysis identified ESRD (HR 1.60), CKD (HR 1.79) and vascular calcifications (HR 1.29) as predictors for 3-year and vascular calcifications (HR 1.51) for 30-day mortality. CONCLUSION: Patients with ESRD and CKD constitute a vulnerable patient group with extensive vascular calcifications. Immediate procedural results were largely unaffected by renal impairment, yielding TAVI a particularly valuable treatment option in these high-risk operative patients. Mid-term survival was determined by underlying renal disease, cardiovascular comorbidities, and vascular calcifications as a novel risk marker.

Prognostic value of the H2 FPEF score in patients undergoing transcatheter aortic valve implantation.

AIMS: The aim of this study was to assess the prognostic value of the H2 FPEF score in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) and preserved left ventricular ejection fraction (EF). METHODS AND RESULTS: In this multicentre study, a total of 832 patients from two German high-volume centres, who received TAVI for severe AS and preserved EF (≥50%), were identified for calculation of the H2 FPEF score. Patients were dichotomized according to low (0-5 points; n = 570) and high (6-9 points; n = 262) H2 FPEF scores. Kaplan-Meier and Cox regression analyses were applied to assess the prognostic impact of the H2 FPEF score. We observed a decrease in stroke volume index (-2.04 mL/m2 /point) and mean transvalvular gradients (-1.14 mmHg/point) with increasing H2 FPEF score translating into a higher prevalence of paradoxical low-flow, low-gradient AS among patients with high H2 FPEF score. One year after TAVI, the rates of all-cause (low vs. high H2 FPEF score: 8.0% vs. 19.4%, P < 0.0001) and cardiovascular (CV) mortality (1.9% vs. 9.0%, P < 0.0001) as well as the rate of CV mortality or rehospitalization for congestive heart failure (6.4% vs. 23.2%, P < 0.0001) were higher in patients with high H2 FPEF score compared with those with low H2 FPEF score. After multivariable analysis, a high H2 FPEF score remained independently predictive of all-cause mortality [hazard ratio 1.59 (1.28-2.35), P = 0.018] and CV mortality or rehospitalization for congestive heart failure [hazard ratio 2.92 (1.65-5.15), P < 0.001]. Among the H2 FPEF score variables, atrial fibrillation, pulmonary hypertension, and elevated left ventricular filling pressure were the strongest outcome predictors. CONCLUSIONS: The H2 FPEF score serves as an independent predictor of adverse CV and heart failure outcome among TAVI patients with preserved EF. A high H2 FPEF score is associated with the presence of paradoxical low-flow, low-gradient AS, the HFpEF in patients with AS. By identifying patients in advanced stages of HFpEF, the H2 FPEF score might be useful as a risk prediction tool in patients with preserved EF scheduled for TAVI.

TAVR for low-flow, low-gradient aortic stenosis: Prognostic impact of aortic valve calcification.

BACKGROUND: Compared to high gradient aortic stenosis (AS), patients with low-flow, low-gradient AS have higher mortality after transcatheter aortic valve replacement (TAVR), but distinct outcome predictors in this patient subset are yet to be determined. The present study investigated the prognostic impact of aortic valve calcification (AVC) in patients with low-flow, low-gradient AS undergoing TAVR. METHODS: This retrospective single-center analysis includes all patients undergoing TAVR for severe low-flow, low-gradient AS (n = 526), ie, low EF low gradient AS (LEF-LG AS; n = 290) and paradoxical low-flow, low-gradient AS (PLF-LG AS; n = 236), in whom AVC was quantified from contrast-enhanced multislice computed tomography images. AVCdensity was defined as calcium volume per annulus area. Patients were trichotomized according to sex-specific AVCdensity tertiles in both subgroups. All-cause mortality was assessed by Kaplan-Meier analyses and independent outcome predictors were determined by multivariable analyses. RESULTS: In both subgroups, patients with high AVCdensity had higher mean transvalvular gradients at baseline and higher rates of PVL after TAVR. High AVCdensity was associated with lowest 1- and 3-year mortality after TAVR in the LEF-LG AS but not in the PLF-LG AS group. According to multivariable analysis AVCdensity was independently associated with better survival in LEF-LG AS patients (HR 0.73 [0.60-0.88], P = .0011), but not in those with PLF-LG AS (HR 0.91 [0.73-1.14], P = .42). CONCLUSIONS: Quantification of AVC may not only be of diagnostic but also of prognostic value, as it facilitates the selection of LEF-LG AS patients with higher probability of beneficial outcome after TAVR.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in low-risk patients: a propensity score-matched analysis.

OBJECTIVES: The aim of the study was to determine the differences in outcomes of surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) in low-risk patients. METHODS: All patients with a logistic EuroSCORE II <4% who underwent transfemoral TAVI between 2008 and 2016 (n = 955) or SAVR between 2009 and 2014 (n = 886) at our centre were included. One hundred and nine patients per group were available for propensity score matching. RESULTS: Mortality during the 30-day follow-up showed no differences (SAVR vs TAVI: 1.1% vs 1.8%, P = 1.0) but the rates of permanent pacemaker implantation (0.0 vs 14.8%, P < 0.001) and paravalvular leakage ≥ moderate (0.0 vs 7.0%, P = 0.017) were higher in TAVI patients. No difference was found regarding postoperative effective orifice area and transvalvular pressure gradients. Although, the 1-year survival was similar between both groups; 3- and 5-year survival was significantly inferior in the TAVI patient cohort. CONCLUSIONS: TAVI yielded similar short-term outcomes compared with SAVR despite higher rates of permanent pacemaker implantation and paravalvular leakage ≥ moderate, but inferior long-term survival. Poorer long-term outcomes of the TAVI patient cohort were attributable to a more comorbid TAVI population. This emphasizes the need for long-term results from randomized controlled trials before TAVI can be broadly expanded to younger low-risk patients.

Comparative analysis of balloon- versus mechanically-expandable transcatheter heart valves considering landing zone calcification.

BACKGROUND: The balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and the mechanically-expandable Lotus valve (Boston Scientific, Marlborough, MA, USA) are established devices for transcatheter aortic valve implantation. We sought to compare both transcatheter heart valves (THV) under consideration of the extent of THV landing zone calcification. METHODS: This retrospective analysis includes consecutive patients with severe aortic stenosis treated with Sapien 3 (S3; n=212) or Lotus (n=61) THV via transfemoral access. Outcome was assessed according to VARC II definitions. Rate of paravalvular leakage (PVL), periprocedural stroke, and permanent pacemaker implantation (PPI) was adjusted for THV landing zone calcification as calculated by multi-slice computed tomography. RESULTS: There was no difference in preoperative risk (all results as follows S3 vs. Lotus: STS-PROM 5.9±5.6% vs. 4.8±2.6%, p=0.14), rate of device success (95.3% vs. 95.1%, p=0.67), 30-day mortality (1.9% vs. 4.9%, p=0.16), periprocedural stroke (1.4% vs. 4.9%, p=0.27), and major access site complications (9.4% vs. 9.8%, p=0.93). PPI was more frequent (19.4% vs. 34.4%, p=0.01) and significant PVL was less frequent (≥mild PVL: 17.6% vs. 3.7%, p=0.04) after Lotus implantation. No association was found between landing zone calcification and periprocedural stroke rate (OR 1.19, 95%CI 0.92-1.54, p=0.17) or need for PPI (OR 1.04, 95%CI 0.91-1.18, p=0.57). The extent of landing zone calcification was associated with risk for PVL ≥mild (OR 1.21, 95%CI 1.03-1.42, p=0.02). After adjusting for landing zone calcification risk for PVL ≥mild was lower with the Lotus valve (OR 0.15, 95%CI 0.02-0.54, p=0.01). CONCLUSION: Both THVs yield comparable procedural and clinical outcomes except for a higher PPI rate with the Lotus valve, which is independent from the extent of landing zone calcification. The extent of landing zone calcification is associated with an increased risk for PVL for both THV, but is significantly reduced with the Lotus valve.

Transcatheter valve-in-valve implantation versus redo surgical aortic valve replacement in patients with failed aortic bioprostheses.

OBJECTIVES: Transcatheter aortic valve-in-valve implantation (ViV) is a new treatment for failing bioprostheses (BP) in patients with high surgical risk. However, comparative data, using standard repeat surgical aortic valve replacement (redo-SAVR), are scarce. We compared outcomes after ViV with those after conventional redo-SAVR in two European centres with established interventional programmes. METHODS: In-hospital databases were retrospectively screened for patients ≥60 years, treated for failing aortic BP. Cases of infective endocarditis or combined procedures were excluded. End-points were adjudicated according to the Valve Academic Research Consortium (VARC-2) criteria. RESULTS: From 2002 to 2015, 130 patients were treated (ViV: n = 71, redo-SAVR: n = 59). Age and logistic EuroSCORE I scores were higher with ViV (78.6 ± 7.5 vs 72.9 ± 6.6 years, P < 0.01; 25.1 ± 18.9 vs 16.8 ± 9.3%, P < 0.01). The 30-day mortality rate was not significantly different (4.2 and 5.1%, respectively) (P = 1.0). Device success was achieved in 52.1% (ViV) and 91.5% (P < 0.01). No stroke was observed after ViV but in 3.4% after redo-SAVR (P = 0.2). Intensive care stay was longer after redo-SAVR (3.4 ± 2.9 vs 2.0 ± 1.8 days, P < 0.01). Mean transvalvular gradients were higher post-ViV (19.7 ± 7.7 vs12.2 ± 5.7 mmHg, P < 0.01), whereas the rate of permanent pacemaker implantation was lower (9.9 vs 25.4%, P < 0.01). Survival rates at 90 and180 days were 94.2 and 92.3% vs 92.8 and 92.8% (P = 0.87), respectively. CONCLUSIONS: Despite a higher risk profile in the ViV group, early mortality rates were not different compared with those of surgery. Although ViV resulted in elevated transvalvular gradients and therefore a lower rate of device success, mortality rates were similar to those with redo-SAVR. At present, both techniques serve as complementary approaches, and allow individualized patient care with excellent outcomes.

First-in-man treatment of a degenerated mitral surgical valve with the mechanical expanding Lotus™ valve.

Percutaneous placement of transcatheter heart valves for treatment of degenerated surgical valves in the aortic and mitral position is an emerging therapy for selected high-risk patients. Here we describe in detail the first case in the literature of a patient (female, 72 years old, log EuroSCORE 22.9%) with a degenerated biological mitral prosthesis which was successfully treated by transapical implantation of a Lotus valve. The case described demonstrates the very controlled feasibility of valve-in-valve treatment for a degenerated mitral bioprosthesis with a mechanically expanding Lotus valve.

MitraClip-data analysis of contemporary literature.

Treatment of mitral regurgitation (MR) with the MitraClip (MC), a percutaneous, transseptal edge-to-edge reconstruction of the mitral valve, has become an interesting treatment option in most patients not eligible for surgery. Lately a variety of studies have been published analyzing the treatment of MR with the MC in degenerative as well as functional MR. The results for both entities of MR show negligible intraprocedural mortality, low periprocedural complications rates and a beneficiary outcome in terms of reduction in MR as well as an improvement in functional capacity and quality of life. Here we summarize the latest results focusing on safety and efficacy of MC treatment.

Transfemoral TAVI without pre-dilatation using balloon-expandable devices: a case-matched analysis.

OBJECTIVES: This comparative case-matched analysis investigated feasibility and safety of direct transfemoral (TF) transcatheter aortic valve implantation (TAVI) without pre-dilatation using balloon-expandable devices. BACKGROUND: Presently, balloon aortic valvuloplasty (BAV) is considered mandatory preceding transfemoral TAVI with balloon-expandable devices. However, procedural severe adverse events may be associated with BAV. METHODS: 26 consecutive patients (study group) received direct TF-TAVI using Edwards Sapien XT (n = 17) or Sapien 3 (n = 9) devices (61.5% female, 81.3 ± 6.3 years, logEuroSCORE I 15.3 ± 13.2%). A control group of patients after conventional TF-TAVI was retrieved from our database containing 1153 TAVI patients and matched to the study group regarding baseline and procedural data. Data reporting adheres to VARC-2 definitions. RESULTS: Device success was 96.2% (25/26) and 92.3% (24/26) in study and control groups, respectively (p = 1.00). Procedure time (60.0 ± 54.0 vs. 70.0 ± 29.1 min; p = 0.41), fluoroscopy time (13.3 ± 5.8 vs. 17.8 ± 6.9 min; p = 0.01) and amount of contrast agent (118.7 ± 47.9 vs. 153.0 ± 53.2 ml; p = 0.02) were lower in the study group. All-cause 30-day mortality was 7.7% (2/26) in both groups, disabling stroke was observed in 3.8% (1/26) and 7.7% (2/26) in study and control groups, respectively. Resultant transvalvular mean gradient and effective orifice area (EOA) were 11 ± 5 vs. 11 ± 5 mmHg and 1.6 ± 0.3 vs. 1.5 ± 0.3 cm(2). Paravalvular leakage ≥ grade II was observed in 0 and 7.7% (2/26; p = 0.49). CONCLUSIONS: TF-TAVI without pre-dilatation was feasible and safe in this consecutive series of patient regardless of aortic valve morphology, for example. extent of valvular calcification or baseline EOA. This technique resulted in significantly lower fluoroscopy times and amounts of contrast agent while yielding non-inferior hemodynamic and clinical outcome.

Blood transfusion is associated with impaired outcome after transcatheter aortic valve implantation.

OBJECTIVES: We sought to evaluate the relationship of blood transfusion after transcatheter aortic valve implantation (TAVI) and mid-term outcome to improve patient selection and periprocedural treatment. BACKGROUND: Increasing evidence suggests a negative influence of blood transfusion on outcomes of patients with cardiovascular diseases. While the adverse impact of bleeding events on survival has been documented after TAVI, data on the impact of postoperative blood transfusions are scarce. METHODS: TAVI was performed in 700 consecutive patients; 14.7% of TAVI patients suffered from bleeding or access site complications and were excluded from analysis to minimize confounding. Outcomes were analyzed with emphasis on blood transfusions and according to the Valve Academic Research Consortium definitions. Median follow-up duration was 364 days. Multivariable analyses were performed to identify predictors for transfusion and 1-year mortality. RESULTS: 33.0% of patients received blood transfusions after TAVI, irrespective of access choice. Blood transfusions were associated with a higher baseline risk profile (median logistic EuroSCORE 21.0 vs. 17.0%), increased rates of postoperative complications and impaired survival (21.2 vs. 36.1% all-cause 1-year mortality). Transfusion was an independent predictor of mortality at 1 year (OR 2.78 [CI 1.59-4.86]). Low body mass index (OR 0.94 [0.89-1.0]), low baseline hemoglobin (OR 0.39 [0.33-0.47]) and combined anticoagulation/antiplatelet therapy were identified as independent predictors of blood transfusion after TAVI. CONCLUSIONS: Blood transfusions were frequently required after TAVI even in the absence of overt bleeding or access site complications and were identified as an independent predictor of impaired mid-term outcome. Optimization of baseline factors, strict blood conservation strategies, and individualized antiplatelet or anticoagulant regimens may improve outcome after TAVI.

Single-centre experience with next-generation devices for transapical aortic valve implantation.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has become an established procedure in patients with aortic stenosis and high surgical risk. Experience with first-generation transcatheter heart valves (THVs) is broad but limitations, e.g. paravalvular regurgitation, have been demonstrated. Much hope rests on the recently Conformité Européenne mark approved next-generation devices to improve results in these patients. However, apart from the initial approval studies, clinical data with these new devices are still scarce. We aimed to assess short-term outcomes of 200 consecutive patients who underwent transapical TAVI with next-generation THV at our institution. METHODS: Transapical TAVI was performed in 200 consecutive patients 80.5±6.7 years old (38.5% female) at high surgical risk (log EuroSCORE 20.2±16.5%). Devices implanted were the Engager (Medtronic, Inc., Minneapolis, MN, USA; n=50), JenaValve (JenaValve Technology, Munich, Germany; n=88) and Symetis Acurate (Symetis SA, Ecublens, Switzerland; n=62) THV that were selected by the heart team on an individual basis. Data at baseline, during the procedure and follow-up were analysed according to standardized Valve Academic Research Consortium end points. Median follow-up was 219 days. RESULTS: Implantation was successful in 96.5% of cases. Valve function improved significantly with an increase in effective orifice area from 0.8±0.4 to 1.8±0.3 cm2 and a reduction in mean transvalvalvular gradients from 34.0±17.0 to 11.2±5.4 mmHg. Paravalvular regurgitation was none or trace in 70.3% of patients, Grade 1 in 26.1%, and Grade 2 in 3.5%. No patients developed aortic regurgitation>Grade 2. Major access site complications occurred in 6.5%, major stroke in 1.5% and stage-3 kidney injury in 2.5% of patients. A permanent pacemaker was implanted in 20.5% of patients overall and in 8.0% for a complete heart block. At 30-day follow-up 72.8% of patients were in New York Heart Association class I or II (10.5% at baseline). Overall survival was 91.5% at 30 days and 73.9% at 1 year. CONCLUSIONS: In a real-world clinical setting, next-generation transapical THV yielded positive haemodynamic results. The incidence of relevant paravalvular regurgitation was scarce in this group and clinical outcomes were encouraging during short-term follow-up. Long-term follow-up is required to investigate the durability of these new devices.

Valve-in-valve implantation of a novel and small self-expandable transcatheter heart valve in degenerated small surgical bioprostheses: the Hamburg experience.

BACKGROUND: Transcatheter valve-in-valve (VIV) implantation has emerged as a novel treatment option in patients with degenerated aortic bioprostheses and high surgical risk. However, VIV implantation in small aortic bioprostheses using first generation TAVI devices has frequently resulted in high postprocedural gradients and small effective orifice areas. Recently, an updated version of the self-expandable Medtronic CoreValve prosthesis, which is particularly suitable for small aortic annuli, has become available. We report on the feasibility and early results of VIV implantation using this novel device in a series of patients with degenerated small aortic bioprostheses. METHODS AND RESULTS: 16 patients from two Hamburg hospitals (age range 72-92 years) underwent implantation of a 23-mm CoreValve Evolut (Medtronic, Minneapolis, MN, USA) transcatheter heart valve into failing aortic bioprostheses with internal diameters below 21 mm. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team mean (logistic EuroSCORE range 9.0-88%). Implantation was successful without relevant remaining aortic regurgitation or signs of stenosis and a marked reduction in postprocedural gradientswas observed in 14 out of 16 patients. The mean gradient was reduced from from 34 mm Hg (SEM 10 mm Hg) to 14 mm Hg (SEM 6 mm Hg). No major device- or procedure-related adverse events occurred during 30-day follow up and clinical improvement was observed. CONCLUSIONS: Failing aortic bioprostheses with small internal diameters continue to be a challenging pathology for TAVI due to the risk of high residual gradients and small aortic orifice areas. This report provides first evidence that the 23-mm CoreValve Evolut, a novel self-expanding prosthesis, provides an improved treatment option in these specific patients due to its low profile which resulted in promising early results. © 2013 Wiley Periodicals, Inc.

The challenge of valve-in-valve procedures in degenerated Mitroflow bioprostheses and the advantage of using the JenaValve transcatheter heart valve.

AIMS: Recently, the feasibility of valve-in-valve procedures using current first-generation transcatheter heart valves (THV) in cases of structural valve degeneration has been reported as an alternative to conventional open repeat valve replacement. By design, certain biological valve xenografts carry a high risk of coronary ostia occlusion due to lateral displacement of leaflets after valve-in-valve procedures. In the present report we aimed to prove feasibility and safety of transapical valve-in-valve implantation of the JenaValve THV in two cases of degenerated Mitroflow bioprostheses. METHODS AND RESULTS: We herein report two cases of successful transapical valve-in-valve procedures using a JenaValve THV implanted in Sorin Mitroflow bioprostheses for structural valve degeneration. Both patients were alive and in good clinical condition at 30 days from the procedure. However, increased transvalvular gradients were noted in both cases. CONCLUSIONS: Transcatheter valve-in-valve implantation of a JenaValve THV is a valid alternative for patients with degenerated Mitroflow bioprostheses of sufficient size and in the presence of short distances to the coronary ostia who are too ill for conventional repeat open heart surgery. Increased pressure gradients have to be expected and weighed against the disadvantages of other treatment options when planning such a procedure.

Transapical transcatheter aortic valve implantation without prior balloon aortic valvuloplasty: feasible and safe.

OBJECTIVES: Currently, preimplant balloon aortic valvuloplasty (BAV) is considered a prerequisite for successful subsequent transapical transcatheter aortic valve implantation (TA-TAVI) using balloon-expandable devices. However, cerebral embolization has been shown to originate at least in part from BAV procedures. Omitting BAV may therefore reduce neurological events after TAVI and facilitate the procedure while yielding non-inferior haemodynamic and clinical outcomes. METHODS: From May 2011 through December 2012, a total of 50 consecutive patients were treated by TA-TAVI without preimplant BAV (TA-TAVI(-BAV), study group) using the Edwards Sapien XT device (54% male, age 78 ± 8 years, logistic European System for Cardiac Operative Risk Evaluation I 21 ± 14%). Data were prospectively entered into a dedicated database, retrospectively analysed and compared with a consecutive series of conventional TA-TAVI using the same device (control group, n = 50). Reporting of data followed Valve Academic Research Consortium definitions. RESULTS: Overall device success rate was 94% (47/50) and 86% (43/50) in study and control groups, respectively (P = 0.32). Procedure time was similar in the study group compared with the control group (88 ± 31 vs 91 ± 25 min, P = 0.60), while significantly less contrast was used (138 ± 68 vs 183 ± 78 ml, P < 0.001). Post-procedural peak and mean transvalvular gradients were 16 ± 7 and 8 ± 3 mmHg, respectively, in the study group with similar values in the control group (19 ± 9 and 9 ± 5 mmHg, P = 0.08 and P = 0.09, respectively). Residual paravalvular leakage (PVL) grade 2 was present in 2 and 8% in study and control groups, respectively (P = 0.36), with no PVL >grade 2 in any patient. Rates of 30-day mortality and periprocedural stroke were 4 and 10% (P = 0.44) and 2 and 6% (P = 0.62), respectively. CONCLUSIONS: TA-TAVI(-BAV) is feasible and safe and has become ur default technique for patients allocated to TA-TAVI with balloon-expandable devices. This approach resulted in less contrast agent used and facilitated the procedure without compromising valve performance. Possible beneficial effects of this approach on the incidence of cerebrovascular events, other periprocedural complications or haemodynamic valve performance need to be verified in larger patient numbers before general recommendations can be made.

Isolated permanent right ventricular assistance using the HVAD continuous-flow pump.

Acute isolated right ventricular (RV) failure from myocardial infarction is a rare scenario. To date, there are no assist devices developed or approved for permanent isolated right heart support. We report on the successful implantation of a HeartWare HVAD as an isolated RV assist in a patient who suffered extended RV myocardial infarction after iatrogenic dissection of the right coronary artery. No manipulations of the system were required to adapt the assist device to the pulmonary circulation.