Transaortic Transcatheter Aortic Valve Implantation Research Articles

Transcatheter Aortic Valve Implantation by Intercostal Access: Initial Experience with a No-Touch Technique.

Transcatheter aortic valve implantation (TAVI) is now a well-established therapeutic option in an elderly high-risk patient cohort with aortic valve disease. Although most commonly performed via a transfemoral route, alternative approaches for TAVI are constantly being improved. Instead of the classical mini-sternotomy, it is possible to achieve a transaortic access via a right anterior mini-thoracotomy in the second intercostal space. We describe our experience with this sternum- and rib-sparing technique in comparison to the classical transaortic approach. Our retrospective study includes 173 patients who were treated in our institution between January 2017 and April 2020 with transaortic TAVI via either upper mini-sternotomy or intercostal thoracotomy. The primary endpoint was 30-day mortality, and secondary endpoints were defined as major postoperative complications that included admission to the intensive care unit and overall hospital stay, according to the Valve Academic Research Consortium 3. Eighty-two patients were treated with TAo-TAVI by upper mini-sternotomy, while 91 patients received the intercostal approach. Both groups were comparable in age (mean age: 82 years) and in the proportion of female patients. The intercostal group had a higher rate of peripheral artery disease (41% vs. 22%, p = 0.008) and coronary artery disease (71% vs. 40%, p < 0.001) with a history of percutaneous coronary intervention or coronary artery bypass grafting, resulting in significantly higher preinterventional risk evaluation (EuroScore II 8% in the intercostal vs. 4% in the TAo group, p = 0.005). Successful device implantation and a reduction of the transvalvular gradient were achieved in all cases with a significantly lower rate of trace to mild paravalvular leakage in the intercostal group (12% vs. 33%, p < 0.001). The intercostal group required significantly fewer blood transfusions (0 vs. 2 units, p = 0.001) and tended to require less reoperation (7% vs. 15%, p = 0.084). Hospital stays (9 vs. 12 d, p = 0.011) were also shorter in the intercostal group. Short- and long-term survival in the follow-up showed comparable results between the two approaches (30-day, 6-month- and 2-year mortality: 7%, 23% and 36% in the intercostal vs. 9%, 26% and 33% in the TAo group) with acute kidney injury (AKI) and reintubation being independent risk factors for mortality. Transaortic TAVI via an intercostal access offers a safe and effective treatment of aortic valve stenosis.

Transaxillary Versus Transaortic Transcatheter Aortic Valve Implantation in the Treatment of Aortic Stenosis: An Updated Systematic Review and Meta-Analysis.

Transcatheter aortic valve replacement (TAVR) is a technique that can be performed through multiple approaches, and the benefits of one approach over another are still being evaluated to make sure patients receive the best possible care. Our meta-analysis aims to compare clinical and procedural outcomes of the transaxillary (TAx) and transaortic (TAo) approaches to validate the more optimal procedure.The systematic literature search was done via PubMed/MEDLINE, Embase, and the Cochrane Central databases from inception to December 2021, to identify articles reporting data on both TAx TAVR and TAo TAVR. In addition, we checked ClinicalTrials.gov for more published or unpublished trials. Baseline patient characteristics, procedure results, and clinical results were extracted from the article and pooled for analysis. A quantitative meta-analysis was conducted using Review Manager (RevMan) version 5.3 (Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark). The outcomes extracted included blood transfusion, conversion to sternotomy, tamponade, contrast amount, procedure time, bleeding incidents (minor, major, or life-threatening), length of stay (LOS), vascular complications (minor or major), acute kidney injury (AKI), paravalvular leak (PVL), permanent pacemaker (PPM) implantation, 30-day mortality, one-year mortality, 30-day stroke, and device success.The final analysis included 11 articles, consisting of 10 observational studies and a pivotal trial. Cumulative results revealed that the TAo approach had a significantly lower incidence of vascular complications (RR = 2.30; 95% CI = 1.22 to 4.35), and the need for implantation of a permanent pacemaker (RR = 1.82; 95% CI = 1.30 to 2.54) along with a lower amount of contrast (mean difference (MD) = 27.40; 95% CI = 3.73 to 51.08) needed to be used. The TAx group was associated with a significantly lower 30-day mortality (RR = 0.46; 95% CI = 0.31 to 0.69), AKI (RR = 0.47; 95% CI = 0.33 to 0.67), and length of hospital stay (MD = −1.95; 95% CI = −2.51 to −1.38). No significant difference was observed between the outcomes of 30-day stroke (RR = 1.38; 95% CI = 0.81 to 2.33), PVL (RR = 1.05; 95% CI = 0.50 to 2.18), tamponade (RR = 0.71; 95% CI = 0.12 to 4.03), conversion to sternotomy (RR = 0.51; 95% CI = 0.06 to 4.30), device success (RR = 0.97; 95% CI = 0.88 to 1.07), the incidence of bleeding (RR = 0.75; 95% CI = 0.51 to 1.10), and procedure time (MD = 4.44; 95% CI = −96.30 to 105.17).Both the procedures were associated with their benefits and risks. Although most of the outcomes favored TAx transcatheter aortic valve implantation (TAVI), it is too early to say if it would be better than TAo TAVI. To authenticate the findings concluded in this meta-analysis and further improve our understanding of the efficacy, safety, and risk profile between TAx and TAo approaches for TAVI, large sample randomized clinical trials are required on a wide scale.

Minireview: Transaortic Transcatheter Aortic Valve Implantation: Is There Still an Indication?

Transaortic (TAo) transcatheter aortic valve implantation has become a valid alternative access route in patients with unsuitable femoral arteries. The current literature does not allow to clearly favor one of the alternative access routes. Every approach has its specific advantages. Transaortic (TAo) access is of particular importance in the case of calcifications of the supra-aortic branches and the aortic arch, as under these circumstances other alternative access routes, such as transaxillary or transcarotid, are not feasible. The purpose of this minireview is to give an overview and update on TAo transcatheter aortic valve implantation focusing on indication, technical aspects, and recent clinical data.

Simultaneous transaortic transcatheter aortic valve implantation and off-pump coronary artery bypass: An effective hybrid approach.

Transcatheter aortic valve implantation (TAVI) techniques are increasingly being adopted into clinical routine for various risk groups. Coronary artery disease (CAD) is seen in up to 75% of patients with severe aortic valve stenosis (AS) presenting with typical angina pectoris. Due to high mortality rates and procedural complications in these patients, a hybrid concept of simultaneous transaortic TAVI and off-pump coronary artery bypass (OPCAB) can be a feasible treatment option. Between April 2014 and July 2020, 10 consecutive high-risk patients underwent concomitant transaortic TAVI and OPCAB at our institution. All indications were discussed in Heart Team and decisions were made based on patients' comorbidities and complexity of CAD. The study endpoints were 30-day mortality, device success, and development of postoperative adverse events defined by the Valve Academic Research Consorium. The mean age of the patients was 77.9 ± 7.1 years old. All patients presented with multiple comorbidities (mean logistic EuroSCORE 26.5 ± 12.3%, median EuroSCORE II 5.13% [interquartile range 4.2-9.5], mean STS-Score 6.04 ± 1.6%). Five patients (50%) presented with porcelain aorta. No conversion to conventional procedures was needed. 30-day mortality occurred in one patient (10%). Complete revascularization was achieved in seven (70%) of the patients. Device success rate was 100%. No paravalvular leakage was detected. No stroke, myocardial infarction or vascular complications were observed. A hybrid approach combining transaortic TAVI and OPCAB might be a safe and feasible method of treatment in high-risk patients presenting with severe AS and CAD who are not eligible for conventional surgical or interventional solutions.

Midterm outcomes of transaortic and transapical TAVI in patients with unsuitable vascular anatomy for femoral access: A propensity score inverse probability weight study.

Transaortic (TAo) and transapical (TA) implantation can be used in transcatheter aortic valve implantation (TAVI) when the transfemoral (TF) approach is precluded. We compare the safety and efficacy of these alternative techniques. From October 2007 to February 2016, TAo and TA patients' data were collected. Propensity score inverse probability of treatment weight (IPTW) method was employed to minimize the impact of no-randomization bias. From our single-center non-TF-TAVI registry, 282 patients were included: 235 (83.3%) underwent TAo and 47 (16.7%) TA. Differences in baseline characteristics were statistically significant in age, sex, risk profile according to logistic-EuroSCORE, and previous cardiac surgery. No difference in hospital morbidity and mortality, but lower stroke-rate in TAo (1.27% vs. 8.5% p < .01) was observed. This was confirmed at logistic regression after IPTW adjustment (odds ratio [OR]: 0.16, 95% CI 0.03-0.71, p = .01), together with reduced risk of the paravalvular leak (PVL) (OR: 0.14, 95% confidence interval [CI]: 0.02-0.81, p = .02). Kaplan-Meier estimates did not demonstrate differences in long-term mortality among access routes (logrank test p = .13). At the IPTW-Cox regression model, long-term mortality was related to New York Heart Association III-IV (hazard ratio [HR]: 2.92, 95% CI: 1.15-7.40, p = .026), chronic renal failure (HR: 3.25; 95% CI: 1.02-10.32 p = .046), previous transient ischemic attack/stroke (HR: 2.29, 95% CI: 1.25-4.20 p = .007). Sapien-3 device resulted to be a protective factor, reducing long-term mortality (HR: 0.18, 95% CI 0.04- 0.90 p = .03). TAo is safe and feasible in case of contraindication to femoral approach demonstrating comparable midterm outcomes to TA, thus representing a central access alternative, to increase the overall safety of high-risk TAVI procedures.

Simultaneous Transaortic Transcatheter Aortic Valve Implantation and Off-Pump Coronary Artery Bypass Grafting for Stenosed Quadricuspid Aortic Valve: Case Report and Review of Literature

Simultaneous Transaortic Transcatheter Aortic Valve Implantation and Off-Pump Coronary Artery Bypass Grafting for Stenosed Quadricuspid Aortic Valve: Case Report and Review of Literature

Comparison of early and midterm outcomes after transsubclavian/axillary versus transfemoral, transapical, or transaortic transcatheter aortic valve implantation

BackgroundOutcomes after transsubclavian/transaxillary (TSc/TAx)-transcatheter aortic valve implantation (TAVI) have been unclear. ObjectivesTo compare outcomes after TSc/TAx-TAVI versus transfemoral (TF)-TAVI, transapical (TAp)-TAVI, or transaortic (TAo)-TAVI, we performed meta-analysis of currently available studies. MethodsStudies considered for inclusion met the following criteria: the study population was patients undergoing TAVI; patients were assigned to TSc/TAx-TAVI and TF-TAVI, TAp-TAVI, or TAo-TAVI; and at least one of postprocedural early (30-day or in-hospital) or late (including early) outcomes was reported. An odds or hazard ratio of each early or late outcome with its 95% confidence interval for TSc/TAx-TAVI versus the other approach was extracted from each individual study and combined in the random-effects model. ResultsOur search identified 15 eligible reports from 12 studies including 10,528 patients. Pooled analysis of early all-cause mortality demonstrated a statistically significant reduction after TSc/TAx-TAVI compared with TAp-TAVI (P = 0.003) or TAo-TAVI (P = 0.03). Pooled analysis of early pacemaker implantation demonstrated a statistically significant increase after TSc/TAx-TAVI compared with TAp-TAVI (P = 0.0001) or TAo-TAVI (P < 0.00001). Pooled analysis of midterm all-cause mortality demonstrated a statistically significant increase after TSc/TAx-TAVI compared with TF-TAVI (P = 0.007). ConclusionsEarly all-cause mortality was lower after TSc/TAx-TAVI than TAp-TAVI or TAo-TAVI, early pacemaker implantation was more frequent after TSc/TAx-TAVI than TAp-TAVI or TAo-TAVI, and midterm all-cause mortality was higher after TSc/TAx-TAVI than TF-TAVI.

Transaortic Transcatheter Aortic Valve Implantation: Learning Curve, Perioperative, and Midterm Follow-Up Results of a Single Center.

We present our initial institutional experience with transaortic (TAo) transcatheter aortic valve implantation (TAVI) using a self-expanding aortic bioprosthesis. A total of 106 patients underwent TAo TAVI with Medtronic CoreValve through a small partial upper sternotomy. We focus our analysis on the overall perioperative results, procedural learning curve (first 30 patients), and midterm follow-up outcomes. VARC-2 device success was achieved in 95 patients (89%), and there were no intraoperative deaths. Nine patients (8.4%) required a second valve and conversion to standard surgery was required in 2 patients (1.8%). The final aortic insufficiency was grade 0 in 65 patients (62%) and grade 1 in 39 (37%). Although patients treated in the TAo TAVI learning phase required a significantly longer radiation time and contrast agent use, device success (93.4% versus 88.2%, P = .7) and prostheses hemodynamics were similar. All-cause mortality at 30 days was 12% (13/106). At a median follow-up of 392 days (IQR: 216-494 days) estimated overall 1-year survival was 72%. No significant differences were reported in terms of 30-day and 1-year observed mortality, and estimated 1-year survival in the learning and later phase of TAo TAVI. TAo TAVI can be performed safely even in the very early phase of the learning curve. Although satisfactory results can be achieved from the beginning, a significant reduction in contrast agent use and radiological exposure are expected as the technique is mastered. Good hemodynamics have been documented and should be further improved with modifications achieved in the TAVI self-expandable valves technology.

Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE†.

There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI. The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization. Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33-24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06-5.06) and pulmonary disease (OR 2.91, 95% CI 1.45-5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34-6.75). Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring. ClinicalTrials.gov identifier: NCT01991431.

Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation

ObjectiveIt has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation. MethodsPatients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (+ balloon aortic valvuloplasty) versus direct (− balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation. ResultsOf the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55). ConclusionsFor many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.

A meta-analysis on clinical outcomes after transaortic transcatheter aortic valve implantation by the Heart Team.

We aimed to perform a meta-analysis on transaortic (TAo) transcatheter aortic valve implantation (TAVI) in order to gain more insight into the safety and efficacy of the approach in addition to the data available from selected centres with small numbers of patients. PubMed and EMBASE were searched on 31 August 2016. The search yielded 251 studies, of which 16 with 1,907 patients were included in the meta-analysis. All were observational, single-arm studies. The rate of conversion to sternotomy was 3.2% (95% CI: 2.3-3.5%; I2=0) among nine studies. Device success among 10 studies was 91% (95% CI: 86.7-94.0%; I2=25.5). Major vascular complications occurred at a rate of 3.1% (95% CI: 1.6-6.0%; I2=60.8). Moderate or severe paravalvular leakage/aortic valve regurgitation (PVL/AR) was reported to be 6.7% (95% CI: 4.3-10.1%; I2=58.9). Permanent pacemaker implantation was required in 11.7% (95% CI: 9.2-14.8%; I2=26.5) of patients. Pooled 30-day post-TAVI complication rates were 9.9% (95% CI: 8.6-11.3%; I2=0) for mortality, 3.7% (95% CI: 2.4-5.6%; I2=28.7) for all stroke, and 1.0% for myocardial infarction (95% CI: 0.5-1.7%; I2=0). The Valve Academic Research Consortium-2 (VARC-2) composite safety endpoint occurred at a pooled rate of 16.7% (95% CI: 10.6-25.3%; I2=58.7). In this meta-analysis of observational studies, transaortic TAVI appears to be a safe procedure with low complication rates.

Transcatheter aortic valve implantation: the transaortic approach.

Background Transcatheter aortic valve implantation has been established as a safe and effective treatment option for patients at high or prohibitive surgical risk. However, some patients may not be suitable for the transfemoral approach due to severe iliofemoral disease or aneurysmal disease of the thoracoabdominal aorta. The aim of this case series was to evaluate the feasibility and clinical outcomes of the transaortic approach. Methods From May 2015 to June 2016, 5 patients (mean age 78.4 ± 3.9 years) with severe symptomatic aortic stenosis underwent transaortic transcatheter aortic valve implantation after a heart team discussion. They were considered to be at high surgical risk and ineligible for the transfemoral approach due to iliofemoral or thoracoabdominal aortic disease. Results A CoreValve Evolut R was successfully deployed in all 5 patients. We performed 4 right mini-parasternal incisions and one J-incision partial sternotomy. None of the patients required permanent pacemaker implantation, one required reopening of the mini-parasternal incision for postoperative bleeding. Follow-up echocardiography one month after the procedure showed improvement in the mean aortic gradient (from 63.2 to 8.3 mm Hg) and aortic valve area (from 0.62 to 2.2 cm2). None of the patients had more than mild paravalvular leakage. There was no intraoperative or 30-day mortality. Conclusion Transaortic transcatheter aortic valve implantation is a safe and feasible option for patients with severe aortic stenosis who are considered unsuitable for transfemoral aortic valve implantation.

Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry.

Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P = 0.76), rates of stroke 2% vs. 0% ( P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% ( P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. NCT01991431.

Transaortic transcatheter aortic valve implantation: experience from the Kiel study

To evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves via transaortic (TAo) access. A total of 100 consecutive patients with severe symptomatic aortic stenosis undergoing TAo-transcatheter aortic valve implantation (TAVI) were included in this observational registry (November 2012-December 2014). Periprocedural and post-procedural outcomes were assessed. Of these 100 patients, 1 received a Medtronic CoreValve. Therefore, this patient was subsequently removed from the analysis. Ninety-nine consecutive TAo-TAVI patients received a balloon-expandable transcatheter heart valve (Sapien). The SAPIEN-XT valve was implanted in 53 patients and the SAPIEN-3 valve in 46 patients. Fluoroscopy time was shorter in the SAPIEN-3 cases (5.6 ± 2.5 vs 8.1 ± 5.1 min, SAPIEN-XT; P = 0.004), with fewer patients requiring dilatation after the operation (20.5% SAPIEN-3 vs 64.2% SAPIEN-XT; P < 0.0001). There were no other significant differences in procedural characteristics between the two valves. All-cause 30-day mortality was 5.1% overall, with comparable outcomes for the two valves (5.7 and 4.4% for SAPIEN-XT and SAPIEN-3 valves, respectively; OR: 1.32; 95% CI: 0.21-8.27; P = 1.0). New atrial fibrillation (13.1%) and acute kidney injury (11.1%) were the most common complications during the 30 days post-procedure. The number of new pacemakers was low (6.1%), with no differences found between the two valve groups. A comparison of 100 TAo- and 42 TA-TAVI implanted in the same period demonstrated similar results in short- (P = 0.31) and long-term (P = 0.99) mortality rates. The efficacy and safety of the Edwards SAPIEN-XT or SAPIEN-3 heart valves via TAo access were demonstrated by high procedural success and low complication rates. The data indicate that this approach is a viable alternative to established access routes.

Poster

Poster

Impact of procedural volume on outcome optimization in transaortic transcatheter aortic valve implantation

BackgroundAn adequate procedural volume seems to be required to minimize the complication rate in TAVI. However, very few studies have investigated the relationship between procedural volume and outcomes in TAVI especially via the transaortic approach. The aim of this study was to evaluate the effect of procedural volume on the outcomes of transaortic TAVI (TAo-TAVI). Methods257 consecutive TAo-TAVI cases performed by 2 cardiac surgeons between January 2011 and June 2014 were included in the current analysis. Cumulative sum (CUSUM) failure analysis of combined 30-day safety endpoints was used in order to evaluate the learning curves. We divided the cases into two groups: early experience and late experience, respectively. Procedure and outcome variables were compared. ResultsThe CUSUM analysis revealed a learning curve regarding the occurrence of adverse events at 30days with an improvement after the initial 128 cases. We divided the cases into two groups (early group: cases 1 to 128; late group: cases 129 to 257). Although the rate of 30-day mortality was not significantly different between the 2 groups (11% and 7%, p=0.268), the incidence of adverse events such as life-threatening bleeding, stroke and AKI was significantly decreased in the late phase group (9% and 1%, p=0.002; 5% and 0%, p=0.014; 16% and 6%, p=0.002, respectively). ConclusionsThe incidence of adverse events was significantly decreased in the late phase group. An appropriate number of procedures seems to be required to reduce the TAo-TAVI complication rate.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively). TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.

Transaortic vs Transapical Approach for TAVI: A single centre experience

Purpose: We present our experience with the transaortic transcatheter aortic valve implantation (TAVI) and compare this to the transapical route.

Early Results of Simultaneous Transaortic Transcatheter Aortic Valve Implantation and Total Arterial Off-Pump Coronary Artery Revascularization in High-Risk Patients.

Transcatheter aortic valve implantation (TAVI) has become an alternative procedure for treating aortic stenosis (AS) in patients with advanced age and severe comorbidities. Ischemic heart disease (IHD) is present with AS in 40-50% of patients with typical angina. Considering the high operative mortality and morbidity rates in these patients, hybrid TAVI and off-pump CABG (OPCAB) have become realistic treatment options. Between August 2014 and November 2015, 12 patients were evaluated for simultaneous TAVI and OPCAB. Because of their advanced age and comorbidities these patients were not considered suitable for standard open heart surgery. PCI was also considered unsuitable, because of left anterior descending artery (LAD) proximal lesions and/or high SYNTAX score. TAVI was conducted through a median sternotomy after left internal thoracic artery (LITA) to LAD anastomosis. In 11 cases OPCAB with LITA and composite RA graft was performed using an aorta no-touch technique. Mean age at operation was 81±6.3 years. Average number of distal anastomoses was 2.6. Perivalvular leakage was mild in 3 patients, trivial in 8, and none in 1. There was no conversion to on-pump procedure and no hospital deaths. Simultaneous transaortic TAVI and OPCAB in high-risk patients with severe AS and IHD is a reasonable option. This method could be an alternative to surgical aortic valve replacement and CABG. (Circ J 2016; 80: 1946-1950).

Transaortic transcatheter aortic valve implantation: Results of the Polish arm of the ROUTE registry.

Transaortic (TAo) transcatheter aortic valve implantation (TAVI) is an alter-native approach in patients considered to be at high risk for classical open surgery with poor peripheral vessel access. The purpose of this study was to determine the feasibility of using TAo access for TAVI procedures employing the Edwards SAPIEN transcatheter heart valve. The primary objective was to determine overall 30-day mortality. A total of 32 patients with severe aortic valve stenosis underwent TAo-TAVI using Edwards SAPIEN bioprostheses. Postoperative results were collected according to the Registry of the Utilization Of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) study protocol. Complications were assessed using Valve Academic Research Consortium- 2 (VARC-2) criteria. The mean age of the population was 80.9 ± 5.2 years, with 53.1% being female. All patients received either the SAPIEN XT or the SAPIEN 3 bioprosthesis (Edwards Lifesciences). Device success was achieved in 100% of cases. One (3.25%) patient subsequently suffered an aortic dissection and required ascending aorta replacement. Paravalvular leakage was absent or mild in 26 (81%) patients, and moderate in 6 (19%) patients. Other complications included permanent pacemaker implantation in 2 (6.5%), and transient post operative delirium in 2 (6.5%) patients. The total hospital stay was 6.7 ± 2.4 days. New York Heart Association class decreased significantly on follow-up. Thirty-day mortality rate was 2 (6.5%) patients. Use of TAo access for TAVI procedures has a reasonable clinical outcome and is a safe alternative to the transfemoral and transapical approaches, especially for patients with high-risk peripheral vessel access.