Transcatheter Aortic Valve Implantation Program Research Articles

Rehospitalization rates after transcatheter aortic valve implantation

Comorbidities pose a major challenge to screening, selection and follow-up of transcatheter aortic valve implantation (TAVI) patients as well as to the procedure itself. The aim of the present study was to assess cardiac and non-cardiac readmission rates besides clinical endpoint data in the first 50 patients of a single center TAVI programme. TAVI was performed using the transfemoral CoreValve system. Procedural success rate was 94%; intraprocedural mortality was 2%. 82% of the patients remained free of a combined safety endpoint at 30 days, and 76.1% remained free of a combined efficacy endpoint at six months (modified criteria of the Valve Academic Research Consortium). At six months, among all surviving patients, 10.3% had experienced readmissions for cardiac causes, and 43.6% had experienced readmissions for non-cardiac causes. Causes of non-cardiac readmissions showed a wide distribution over various medical disciplines, reflecting the high rate of comorbidities. Beyond six months until a predefined reference date (mean follow up 9.9 months), the probability of hospitalization fell by half (1.54 vs. 0.74 hospital days per patient per month), driven by a decrease of non-cardiac readmissions. Karnofsky score before and after TAVI yielded a significant and sustained improvement of performance status, as assessed retrospectively at reference date. The findings of the present study suggest that the high prevalence of comorbidities in high-risk TAVI patients results in a high rate of non-cardiac rehospitalizations during the first 6 months of follow-up. Despite this fact, improvement of global everyday performance following TAVI as perceived by the patients seems to be substantial.

Single center experience with transcatheter aortic valve implantation using the Edwards SAPIEN™ Valve

Objectives. The use of transcatheter aortic valve implantation (TAVI) for high-risk patients was introduced in the early 2000s for treatment of aortic valve stenosis patients with too high surgical risk. During the last years, there has been a dramatic increase in TAVI procedures. TAVI programs are implemented in numerous cardiac centers. This paper describes a single center experience with its first 100 TAVI procedures. Methods. This study included the first 100 patients who were scheduled for either transfemoral (F-TAVI) or transapical (A-TAVI) aortic valve implantation at Aarhus University Hospital, Skejby, using the Edwards SAPIEN™ valve. The indication for TAVI was unacceptable high predicted risk associated with conventional surgery. Patients with adequate diameter of iliac arteries were scheduled for F-TAVI, otherwise A-TAVI was preferred. Results. The patients were treated between February 2006 and June 2010. Of these were 44% males and 56% females with a mean (S.D.) age of 81 (7.0). Thirty-days mortality rate was 8%, and decreased from 12% among the first 50 patients to 4% for the last 50 patients. Successful implantation was achieved in 92% patients. Major non-fatal complications were seen in 5% of 76 A-TAVI and in 0% of 24 F-TAVI patients. Mean (S.D.) EuroSCORE in the F-TAVI and A-TAVI groups was 15.9 (9.4) and 21.5 (14), respectively (p = 0.06). Post-procedural leakage of cardiac biomarkers was significantly higher in the A-TAVI group as compared to in the F-TAVI group. Mean (S.D.) NYHA class improved from 2.9 (0.6) to 1.8 (0.7) p < 0.001, with no significant difference between A-TAVI and F-TAVI patients. Conclusion. In surgically non-amenable patients, TAVI can be performed with acceptable mortality and morbidity and results in marked functional improvement. A decrease in 30-day mortality over time indicated a learning curve when implementing this treatment.

Nursing Perspective of Transcatheter Aortic Valve Implantation

Background. With an increasingly elderly population, we are seeing more patients with multiple comorbidities unable to have surgical repair of their aortic valves. Transcatheter aortic valve implantation (TAVI) is now an option available for these patients, and the cath labs need to get prepared. Objective. To provide the nurses who will soon be offering TAVI in their cath labs an inside look at our program to help them prepare for this new innovative procedure. Methods. Through a description of our practice and sharing my perspective of our TAVI program, cath lab staff will have a good idea of what to expect and how to prepare for a TAVI program. Conclusion. Sharing experiences is a positive way to initiate new programs in any hospital setting.

Transcatheter treatment approaches for aortic valve disease

Transcatheter aortic valve implantation (TAVI) for the management of symptomatic aortic stenosis has evolved rapidly over the last ten years, to the point where TAVI has recently been established as the standard of care for inoperable patients. With the results of further trials, steady improvements in device design and a greater understanding, it is anticipated that the indications for TAVI will expand to include patients at high risk of complications from surgical aortic valve replacement. As we see the widespread implementation of TAVI programs worldwide, it is timely for a review on the current status of percutaneous transarterial implantation of the aortic valve.

Transcatheter Aortic Valve Implantation (TAVI) for Severe Aortic Stenosis, Experience from the Flinders Medical Centre

Background: The Flinders Medical Centre TAVI program was established in 2008 and since its inception 56 patients with severe aortic stenosis have undergone TAVI. Methods: Audit data obtained over the last three years was analysed to determine patient trends and one-month outcomes for patients undergoing TAVI for severe aortic stenosis with Edward-Sapiens valves. Forty-one percent of patients underwent TAVI via the transapical approach with the remaining patients receiving TAVI via the transfemoral route. The 26 mm prosthesis was implanted in the majority of cases (76.8%) with remaining patients receiving the 23 mm valve. Results: The mean age of patients undergoing TAVI at our institution was 83.9 ± 7.3 years. Significant coronary disease was present in 48.2% of patients undergoing TAVI with 35.7% having undergone previous coronary bypass surgery. Other significant comorbidities included: peripheral vascular disease 14.3%, renal dysfunction 19.6%, and chronic obstructive pulmonary disease17.9%. Significant left ventricular dysfunction was present in 33.9% of cases and 12.5% of patients had a porcelain aorta. Mean annular diameter was 23.2 ± 2 mm. The mean logistic Euroscore was 37.3 ± 17.3 and mean NYHA class was 2.8 ± 0.6. One month mortality was 7% with one procedural death. Twenty-eight out of the 34 patients (82.4%) with one-year follow up survived to one year. None of our patients developed procedural conduction abnormalities but two patients (3.6%) required pacemaker implantation prior to one-month follow-up. Conclusions: Our data suggests that TAVI may be a viable alternative to conventional surgical aortic valve replacement in this high risk cohort of patients.

093 Treatment of high risk aortic stenosis in 2010—more than just TAVI

Introduction The treatment of high risk patients with severe aortic stenosis (AS) has been transformed by the availability of transcatheter aortic valve implantation (TAVI) alongside conventional high risk aortic valve replacement (AVR). Selection of patients for this procedure is clinically challenging and best achieved using a dedicated and experienced multidisciplinary team (MDT). A TAVI programme was established at our institution in September 2008 and the MDT from the outset comprised two interventional cardiologists, an imaging specialist, two cardiac surgeons, cardiac anaesthetist, general cardiologist and a nurse specialist. We report the MDT decision and outcome of 135 patients referred over the subsequent 15 months and the implication on service provision for all aspects of the management of AS. Methods Clinical details of all patients referred to the high-risk aortic stenosis MDT were recorded and analysed prospectively. Outcome data were derived from the hospital database. Results One thirty five patients (mean age 82 years, 50% male) were referred to the high-risk AS MDT (51% local cardiologists, 4% local surgeons, 34% DGH, 11% out of region). Many patients were referred with sufficient data to allow decision making and 45 underwent detailed assessment prior to consideration of TAVI (either following an index inpatient event or during elective admission). To date, 29 of the 135 referred (20%, mean logistic Euroscore 20%) have undergone TAVI (nine apical and 20 femoral) with one (3.4%) procedural mortality, 30-day survival rate 90% and post-TAVI permanent pacemaker requirement 31%. Ten patients (mean logistic Euroscore 22%) were unsuitable for TAVI but appropriate for palliative balloon valvuloplasty either due to significant left ventricular impairment or the presence of co-existent disease with impact on life expectancy. This procedure was undertaken with no in-hospital mortality, a mean reduction in trans-valvular gradient of 25% and a 30-day mortality of 5%. Thirteen patients (mean logistic Euroscore 17.6%) have been referred for high risk AVR. There was one death (8%) 47 days post-AVR. Continued medical therapy was recommended in 27 patients (20 excessive risk or unsuitable for TAVI or valvuloplasty, seven non-severe AS or alternative irreversible aetiology for symptoms eg, pulmonary disease). Overall 12-month mortality for the entire cohort was 20%, highest mortality being seen in those patients deemed too high risk for any form of intervention (41%). Two patients died of AS while the TAVI programme was being conceived. Conclusion Many patients with severe AS previously felt to be at excess risk for any intervention may be suitable for TAVI, surgical AVR or balloon valvuloplasty. Careful patient selection undertaken by a specialist MDT leads to excellent survival outcomes even in this high-risk patient population. The introduction of TAVI has increased surgical referral for AVR and re-introduced balloon valvuloplasty as a successful method of treatment.

Paravalvular regurgitation one year after transcatheter aortic valve implantation

The aim of this study was to assess the natural history of paravalvular regurgitation at 1 year in patients undergoing TAVI. The immediate incidence of paravalvular regurgitation is estimated to be between 65 and 85% following transcatheter aortic valve implantation (TAVI). There is limited data as to whether this deteriorates during follow-up. Forty-six patients were recruited from a TAVI programme at our institute. All patients underwent an assessment of prosthetic valve function periprocedurally with aortography and immediately postprocedurally with transthoracic echocardiography. Twenty-one patients with a median age was 83 (66-91) years of whom 14 were male reached 1 year follow-up, 13 of whom were available for repeat transthoracic echocardiography. The incidence of paravalvular regurgitation immediately following TAVI was 86%. Of them 57% had < or = mild regurgitation and 29% had > mild regurgitation. At 1 year the incidence of paravalvular regurgitation was 77%. 54% had < or = mild regurgitation and 34% > mild regurgitation. No patient had severe regurgitation. The degree of regurgitation reduced in 6 (46%), stayed the same in 3 (23%), and increased in 4 (31%) of patients. Patients undergoing TAVI have an immediate postprocedural risk of regurgitation of 86%. In the majority of cases the degree of paravalvular CoreValve regurgitation is mild, and remains stable in 70% of patients during medium term follow-up.

Transcatheter Aortic Valve Implantation for the Treatment of Severe Symptomatic Aortic Stenosis in Patients at Very High or Prohibitive Surgical Risk: Acute and Late Outcomes of the Multicenter Canadian Experience

The aim of this study was: 1) to evaluate the acute and late outcomes of a transcatheter aortic valve implantation (TAVI) program including both the transfemoral (TF) and transapical (TA) approaches; and 2) to determine the results of TAVI in patients deemed inoperable because of either porcelain aorta or frailty. Very few data exist on the results of a comprehensive TAVI program including both TA and TF approaches for the treatment of severe aortic stenosis in patients at very high or prohibitive surgical risk. Consecutive patients who underwent TAVI with the Edwards valve (Edwards Lifesciences, Inc., Irvine, California) between January 2005 and June 2009 in 6 Canadian centers were included. A total of 345 procedures (TF: 168, TA: 177) were performed in 339 patients. The predicted surgical mortality (Society of Thoracic Surgeons risk score) was 9.8 +/- 6.4%. The procedural success rate was 93.3%, and 30-day mortality was 10.4% (TF: 9.5%, TA: 11.3%). After a median follow-up of 8 months (25th to 75th interquartile range: 3 to 14 months) the mortality rate was 22.1%. The predictors of cumulative late mortality were peri-procedural sepsis (hazard ratio [HR]: 3.49, 95% confidence interval [CI]: 1.48 to 8.28) or need for hemodynamic support (HR: 2.58, 95% CI: 1.11 to 6), pulmonary hypertension (PH) (HR: 1.88, 95% CI: 1.17 to 3), chronic kidney disease (CKD) (HR: 2.30, 95% CI: 1.38 to 3.84), and chronic obstructive pulmonary disease (COPD) (HR: 1.75, 95% CI: 1.09 to 2.83). Patients with either porcelain aorta (18%) or frailty (25%) exhibited acute outcomes similar to the rest of the study population, and porcelain aorta patients tended to have a better survival rate at 1-year follow-up. A TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for the treatment of patients at very high or prohibitive surgical risk, including porcelain aorta and frail patients. Baseline (PH, COPD, CKD) and peri-procedural (hemodynamic support, sepsis) factors but not the approach determined worse outcomes.

ACUTE EFFECTS OF PASSIVE SMOKING ON PULMONARY ARTERY STIFFNESS IN HEALTHY VOLUNTEERS

Aortic stenosis is the most common type of valve disease in the adults. Until recently its treatment was an exclusive domain of cardiac surgery. At the same time the aortic valve replacement (SAVR) was not indicated in about 1/3 of the patients, though the prognosis of conservatively treated patients is very unfavourable with one-year mortality rate of 50%. These facts were the main reasons for starting a new interventional era of the aortic valve disease therapy in 2002 and from 2007 two types of valves fixed in stents have been commercially available.In the early phase the transcatheter aortic valve implantation (TAVI) was used just in patients with contraindication to SAVR or with high perioperative risk after surgery. Before applying this therapy to less risky patients some problems have to be solved: 1. clinical impact of the relatively high rate of paravalvular leaks and 2. long-term function of the implanted valve in follow-up exceeding 5 years.In the Czech Republic the first TAVI was performed in Prague, IKEM in December 2008. During a short period of time the TAVI programme was initiated also in other complex cardiovascular centres in Hradec Kralove, Brno, Prague—FN Kralovske Vinohrady and Trinec. Including the later starting centres (Usti n. Labem, Olomouc, Ceske Budejovice and other three centres in Prague—Nemocnice na Homolce, FN Motol and VFN) there is a total of 11 centres providing the TAVI at present. All centres except one (FN Motol) are part of the Czech TAVI Registry that was developed with the support of the Czech Society of Cardiology and started on 1 September, 2010. In general and more theoretically there are two parts of the Registry: 1. “Retrospective” including all the TAVI procedures from the beginning of the TAVI programme in the Czech Republic that was terminated on June 30, 2011 and 2. “Prospective” that has been following. Institute of Biostatistics and Analyses of Masaryk University takes care of the online and anonymized database.The results of the national Czech TAVI Registry should help to answer the clinical relevant questions mentioned above.