Saib Khogali

CoreValve transcatheter aortic valve implantation via the subclavian artery: comparison with the transfemoral approach.

To the Editor: Transcatheter aortic valve implantation (TAVI) has emerged as a promising alternative to surgical aortic valve replacement for patients with severe aortic stenosis considered to be at high operative risk. TAVI is most commonly performed via the femoral artery. However, the large-

Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Valve: United Kingdom Experience

OBJECTIVES This study sought to present the U.K. experience to date with the second-generation LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts). BACKGROUND First-generation transcatheter aortic valves have limitations. Second-generation repositionable valves may improve on some of those limitations. METHODS Prospectively collected data relating to procedural and in-hospital outcome was analyzed from 10 implantation centers in the United Kingdom. RESULTS Implants in 228 patients age 81.4 ± 7.6 years were studied; 53.5% were male. Mean logistic EuroScore was 17.5 ± 12.4. One hundred eighty-seven (82.0%) were undertaken for aortic stenosis, 7 (3.1%) for aortic regurgitation, and 34 (14.9%) for mixed aortic valve disease. A total of 67.1% of cases were done under local anesthetic and/or sedation with transfemoral access in 94.7% and transaortic in 5.3%. Three device sizes were used: 23 mm (n = 66, 28.9%), 25 mm (n = 39, 17.1%), and 27 mm (n = 123, 53.9%). The valve was successfully deployed in 99.1% of procedures. After implantation, the mean aortic gradient was 11.4 ± 5.4 mm Hg and aortic valve area 1.6 ± 0.5 cm(2). In-hospital mortality was 1.8% (n = 4). Complications included cardiac tamponade (1.8%), conversion to sternotomy (1.3%), stroke (3.9%), vascular access-related (7.0%), and acute kidney injury (7.9%). The incidence of moderate/severe aortic regurgitation was 0.8% (n = 2). A total of 31.8% of patients required new permanent pacemaker implantation. CONCLUSIONS This analysis represents the largest published series on use of the LOTUS valve. Outcomes using this valve are excellent. In-hospital mortality is very low. Complication rates are low, and the LOTUS valve improves on first-generation valves, particularly with regard to residual aortic regurgitation.

Percutaneous Closure of Postinfarction Ventricular Septal Defect In-Hospital Outcomes and Long-Term Follow-Up of UK Experience

Background— Postinfarction ventricular septal defect carries a grim prognosis. Surgical repair offers reasonable outcomes in patients who survive a healing phase. Percutaneous device implantation represents a potentially attractive early alternative. Methods and Results— Postinfarction ventricular septal defect closure was attempted in 53 patients from 11 centers (1997–2012; aged 72±11 years; 42% female). Nineteen percent had previous surgical closure. Myocardial infarction was anterior (66%) or inferior (34%). Time from myocardial infarction to closure procedure was 13 (first and third quartiles, 5–54) days. Devices were successfully implanted in 89% of patients. Major immediate complications included procedural death (3.8%) and emergency cardiac surgery (7.5%). Immediate shunt reduction was graded as complete (23%), partial (62%), or none (15%). Median length of stay after the procedure was 5.0 (2.0–9.0) days. Fifty-eight percent survived to discharge and were followed up for 395 (63–1522) days, during which time 4 additional patients died (7.5%). Factors associated with death after postinfarction ventricular septal defect closure included the following: age (hazard ratio [HR]=1.04; P=0.039), female sex (HR=2.33; P=0.043), New York Heart Association class IV (HR=4.42; P=0.002), cardiogenic shock (HR=3.75; P=0.003), creatinine (HR=1.007; P=0.003), defect size (HR=1.09; P=0.026), inotropes (HR=4.18; P=0.005), and absence of revascularization therapy for presenting myocardial infarction (HR=3.28; P=0.009). Prior surgical closure (HR=0.12; P=0.040) and immediate shunt reduction (HR=0.49; P=0.037) were associated with survival. Conclusions— Percutaneous closure of postinfarction ventricular septal defect is a reasonably effective treatment for these extremely high-risk patients. Mortality remains high, but patients who survive to discharge do well in the longer term.Background— Postinfarction ventricular septal defect carries a grim prognosis. Surgical repair offers reasonable outcomes in patients who survive a healing phase. Percutaneous device implantation represents a potentially attractive early alternative. Methods and Results— Postinfarction ventricular septal defect closure was attempted in 53 patients from 11 centers (1997–2012; aged 72±11 years; 42% female). Nineteen percent had previous surgical closure. Myocardial infarction was anterior (66%) or inferior (34%). Time from myocardial infarction to closure procedure was 13 (first and third quartiles, 5–54) days. Devices were successfully implanted in 89% of patients. Major immediate complications included procedural death (3.8%) and emergency cardiac surgery (7.5%). Immediate shunt reduction was graded as complete (23%), partial (62%), or none (15%). Median length of stay after the procedure was 5.0 (2.0–9.0) days. Fifty-eight percent survived to discharge and were followed up for 395 (63–1522) days, during which time 4 additional patients died (7.5%). Factors associated with death after postinfarction ventricular septal defect closure included the following: age (hazard ratio [HR]=1.04; P =0.039), female sex (HR=2.33; P =0.043), New York Heart Association class IV (HR=4.42; P =0.002), cardiogenic shock (HR=3.75; P =0.003), creatinine (HR=1.007; P =0.003), defect size (HR=1.09; P =0.026), inotropes (HR=4.18; P =0.005), and absence of revascularization therapy for presenting myocardial infarction (HR=3.28; P =0.009). Prior surgical closure (HR=0.12; P =0.040) and immediate shunt reduction (HR=0.49; P =0.037) were associated with survival. Conclusions— Percutaneous closure of postinfarction ventricular septal defect is a reasonably effective treatment for these extremely high-risk patients. Mortality remains high, but patients who survive to discharge do well in the longer term. # CLINICAL PERSPECTIVE {#article-title-23}

Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters’ Registry

OBJECTIVES The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. BACKGROUND The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. METHODS Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. RESULTS A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. CONCLUSIONS This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.

Critical aortic stenosis in a patient with a large saccular abdominal aortic aneurysm: simultaneous transcatheter aortic valve implantation and drive-by endovascular aortic aneurysm repair.

Elderly patients with aortic stenosis are often deemed too high risk, and consequently turned down for conventional surgery. Transcatheter aortic valve implantation (TAVI) is a safe and an increasingly attractive option in this group of patients. Although TAVI has been shown to be successful and safe, the cardiovascular assessment of other co‐morbidities in this susceptible group of patients is critical to ensuring good clinical outcomes. The presence of a saccular abdominal aortic aneurysm (AAA) in our patient was an example of an important co‐morbidity which could have a significant impact on the outcome of TAVI, if not managed appropriately. The increased systolic pressure post successful TAVI will result in an increased strain within the wall of the saccular AAA with an increased risk of rupture. Therefore, a timely management strategy for the AAA was necessary. We believe that we report the first case of simultaneous TAVI and endovascular aneurysm repair (EVAR). The patient underwent uncomplicated transfemoral TAVI immediately followed by successful drive‐by percutaneous EVAR delivered over the same superstiff guidewire via the transfemoral route. Our case highlights the importance of a detailed assessment in all patients before consideration for TAVI, and the multi‐disciplinary team and a management strategy for both pathologies tailored to the patient. The case demonstrates the versatility of trans‐catheter techniques which has enabled the treatment of aortic stenosis and abdominal AAA in a single procedure.

Transcatheter Aortic Valve Implantation With or Without Percutaneous Coronary Artery Revascularization Strategy: A Systematic Review and Meta‐Analysis

Background Recent recommendations suggest that in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and coexistent significant coronary artery disease, the latter should be treated before the index procedure; however, the evidence basis for such an approach remains limited. We performed a systematic review and meta‐analysis to study the clinical outcomes of patients with coronary artery disease who did or did not undergo revascularization prior to transcatheter aortic valve implantation. Methods and Results We conducted a search of Medline and Embase to identify studies evaluating patients who underwent transcatheter aortic valve implantation with or without percutaneous coronary intervention. Random‐effects meta‐analyses with the inverse variance method were used to estimate the rate and risk of adverse outcomes. Nine studies involving 3858 participants were included in the meta‐analysis. Patients who underwent revascularization with percutaneous coronary intervention had a higher rate of major vascular complications (odd ratio [OR]: 1.86; 95% confidence interval [CI], 1.33–2.60; P=0.0003) and higher 30‐day mortality (OR: 1.42; 95% CI, 1.08–1.87; P=0.01). There were no differences in effect estimates for 30‐day cardiovascular mortality (OR: 1.03; 95% CI, 0.35–2.99), myocardial infarction (OR: 0.86; 95% CI, 0.14–5.28), acute kidney injury (OR: 0.89; 95% CI, 0.42–1.88), stroke (OR: 1.07; 95% CI, 0.38–2.97), or 1‐year mortality (OR: 1.05; 95% CI, 0.71–1.56). The timing of percutaneous coronary intervention (same setting versus a priori) did not negatively influence outcomes. Conclusions Our analysis suggests that revascularization before transcatheter aortic valve implantation confers no clinical advantage with respect to several patient‐important clinical outcomes and may be associated with an increased risk of major vascular complications and 30‐day mortality. In the absence of definitive evidence, careful evaluation of patients on an individual basis is of paramount importance to identify patients who might benefit from elective revascularization.

Permanent Pacemaker Insertion After CoreValve Transcatheter Aortic Valve Implantation

Background— Permanent pacemaker (PPM) requirement is a recognized complication of transcatheter aortic valve implantation. We assessed the UK incidence of permanent pacing within 30 days of CoreValve implantation and formulated an anatomic and electrophysiological model. Methods and Results— Data from 270 patients at 10 centers in the United Kingdom were examined. Twenty-five patients (8%) had preexisting PPMs; 2 patients had incomplete data. The remaining 243 were 81.3±6.7 years of age; 50.6% were male. QRS duration increased from 105±23 to 135±29 milliseconds ( P <0.01). Left bundle-branch block incidence was 13% at baseline and 61% after the procedure ( P <0.001). Eighty-one patients (33.3%) required a PPM within 30 days. Rates of pacing according to preexisting ECG abnormalities were as follows: right bundle-branch block, 65.2%; left bundle-branch block, 43.75%; normal QRS, 27.6%. Among patients who required PPM implantation, the median time to insertion was 4.0 days (interquartile range, 2.0 to 7.75 days). Multivariable analysis revealed that periprocedural atrioventricular block (odds ratio, 6.29; 95% confidence interval, 3.55 to 11.15), balloon predilatation (odds ratio, 2.68; 95% confidence interval, 2.00 to 3.47), use of the larger (29 mm) CoreValve prosthesis (odds ratio, 2.50; 95% confidence interval, 1.22 to 5.11), interventricular septum diameter (odds ratio, 1.18; 95% confidence interval, 1.10 to 3.06), and prolonged QRS duration (odds ratio, 3.45; 95% confidence interval, 1.61 to 7.40) were independently associated with the need for PPM. Conclusion— One third of patients undergoing a CoreValve transcatheter aortic valve implantation procedure require a PPM within 30 days. Periprocedural atrioventricular block, balloon predilatation, use of the larger CoreValve prosthesis, increased interventricular septum diameter and prolonged QRS duration were associated with the need for PPM. # Clinical Perspective {#article-title-42}Background— Permanent pacemaker (PPM) requirement is a recognized complication of transcatheter aortic valve implantation. We assessed the UK incidence of permanent pacing within 30 days of CoreValve implantation and formulated an anatomic and electrophysiological model. Methods and Results— Data from 270 patients at 10 centers in the United Kingdom were examined. Twenty-five patients (8%) had preexisting PPMs; 2 patients had incomplete data. The remaining 243 were 81.3±6.7 years of age; 50.6% were male. QRS duration increased from 105±23 to 135±29 milliseconds (P<0.01). Left bundle-branch block incidence was 13% at baseline and 61% after the procedure (P<0.001). Eighty-one patients (33.3%) required a PPM within 30 days. Rates of pacing according to preexisting ECG abnormalities were as follows: right bundle-branch block, 65.2%; left bundle-branch block, 43.75%; normal QRS, 27.6%. Among patients who required PPM implantation, the median time to insertion was 4.0 days (interquartile range, 2.0 to 7.75 days). Multivariable analysis revealed that periprocedural atrioventricular block (odds ratio, 6.29; 95% confidence interval, 3.55 to 11.15), balloon predilatation (odds ratio, 2.68; 95% confidence interval, 2.00 to 3.47), use of the larger (29 mm) CoreValve prosthesis (odds ratio, 2.50; 95% confidence interval, 1.22 to 5.11), interventricular septum diameter (odds ratio, 1.18; 95% confidence interval, 1.10 to 3.06), and prolonged QRS duration (odds ratio, 3.45; 95% confidence interval, 1.61 to 7.40) were independently associated with the need for PPM. Conclusion— One third of patients undergoing a CoreValve transcatheter aortic valve implantation procedure require a PPM within 30 days. Periprocedural atrioventricular block, balloon predilatation, use of the larger CoreValve prosthesis, increased interventricular septum diameter and prolonged QRS duration were associated with the need for PPM.

25 TAVI operator radiation dose compared to PCI and ICD operators: do we need additional radiation protection for trans-catheter structural heart interventions

Introduction Trans-catheter cardiac aortic valve implantation (TAVI), implantable cardiac defibrillators (ICD), and percutaneous coronary intervention (PCI), are common procedures associated with radiation exposure to the operator and the patient. Radiation dose exposure is cumulative and if above the recommended annual levels may have significant consequences for the operator. The radiation dose TAVI operators are exposed to is not widely known, but it is an important consideration in view of the increasing volume of procedures and the potential risks of over-exposure. Our aim was to monitor and compare, radiation exposure time, dose, and individual operator dose, in TAVI, PCI and ICD. Method Ten TAVIs were performed, 6 via the trans-femoral route and 4 via the subclavian approach. Radiation protection was employed in all cases using standard lead skirts and screens. During each procedure the radiation dose exposure was monitored for each operator using ThermoLuscent Dosemeters (TLD) on the left finger (LF), right finger (RF) and forehead. The six TAVI procedures performed via the transfemoral approach used only two operators, while the subclavian approach involved three operators. The third operator was a surgeon who was nearest to the x-ray images. Radiation exposure doses were also collected from ICD and PCI operators during the same period, using the same type of TLDs on LF and RF. Operator specific radiation doses were obtained from a central RRPPS Approved Dosimetry Service. PCI was considered a standard trans-catheter procedure. TAVI and ICD operator doses were compared to the mean standardised PCI operator dose. Results The mean exposure times and doses for the different types of trans-catheter procedures performed are detailed in the tables below. Despite the use of standard radiation protection measures, the mean dose to operators undertaking TAVI was 6 times higher than the trans-femoral PCI operator (p=0.008). The mean radiation exposure time of TAVI was seven times more than PCI. Although subclavian TAVI and ICD procedures were expected to be comparable with respect to operator dose, subclavian TAVI operators have an unexpectedly higher dose (p=0.03). Conclusions Overall TAVI operators are exposed to significantly higher radiation doses compared to PCI and ICD operators. Additional radiation protection for TAVI operators is strongly advocated. We are currently evaluating the impact of using a RADPAD as additional protection during TAVI procedures.Abstract 25 Table 1 Variable TAVI ICD PCI p Value Mean exposure Time (mins) 27.0* 3.26 3.825 <0.001* Mean exposure Dose (Gy/cmq) ± SD 196.25±150.96† 11.03±9.01 33.09±11.5 0.008†* Significantly increased radiation exposure time in TAVI procedures compared to ICD and PCI.† Significantly increased radiation exposure dose in TAVI procedures compared to ICD and PCI.Abstract 25 Table 2 Mean radiation dose (Gy/cmq) per operator ±SD p value Trans-femoral TAVI 1.67 1.23 0.03 Subclavian TAVI 2.53 3.09 0.03 ICD 1.95 0.14 0.03 PCI 0.18 0.36

Incidental abnormal CT scan findings during transcatheter aortic valve implantation assessment: incidence and implications

Objectives The aim of this retrospective series is to describe the prevalence and clinical significance of the incidental findings found during pre–transcatheter aortic valve implantation (TAVI) work-up and to ascertain the clinical course of such patients. Methods Consecutive patients undergoing TAVI from 2013 to 2015 where a TAVI CT assessment was performed (n=138) were included in the study. All incidental findings that were not expected from the patient’s history were discussed at the TAVI multidisciplinary meeting in order to ascertain the clinical significance of said findings and whether they would alter the proposed course of treatment. Mortality data were determined by careful retrospective case note and follow-up appointment analysis. Results Seventy-eight patients (57%) were found to have incidental findings on pre-TAVI CT scan. The majority of patients had benign pathology with high incidence in particular of diverticular disease, pleural effusions, gallstones, hiatus hernia and degenerative spinal disease. Vascular pathology such as superior mesenteric, renal and iliac artery stenoses and abdominal aortic aneurysm was detected in seven patients. In terms of long-term mortality data, we found no significant difference between those with incidental findings and those without (p=0.48). Survival as assessed by Kaplan-Meier analysis showed no significant difference between those with and without incidental abnormal CT scan findings (p=0.98). Conclusions Incidental findings with potential for malignancy are common in an elderly, comorbid population. Ultimately, clinical correlation and prognosis must be swiftly ascertained in order to streamline the patients down the appropriate management pathway while avoiding unnecessary delay for treatment of their aortic stenosis.

Transcatheter aortic valve implantation in decompensated aortic stenosis within the same hospital admission: early clinical experience

Objective Severe decompensated aortic valve stenosis is associated with noticeable reduction in survival. Until recently the options for such patients were either high-risk surgery or percutaneous balloon valvuloplasty and medical therapy which does not add any survival benefits and associated with high rate of complications. We present our experience in the use of transcatheter aortic valve implantation (TAVI) in patients with decompensated severe aortic stenosis requiring urgent intervention in the same hospital admission. Methods In this observational study, all patients who were admitted with decompensated severe aortic stenosis were enrolled. Elective patients were excluded from the study. Perioperative records were analysed and clinical, echocardiographic and survival data were presented. Results 76 patients with a mean age of 81±6 years were enrolled. All patients presented with New York Heart Association (NYHA) IV status. Femoral approach was performed in 86.8%. Median postoperative hospital stay was 6 days and intensive care unit admission rate was 15%. At follow-up, 61.8% of patients were in NYHA status I/II. Moderate or more paravalvular leak occurred in 5.2% of patients. Permanent pacemaker was required in 14.4% of patients. The incidence of in-hospital death was 2.6%. Kaplan-Meier analysis indicated a survival rate of 81% at 1 year. Conclusions Urgent in-hospital TAVI is feasible as the first-line treatment in decompensated severe aortic stenosis. In our cohort, it showed to be safe and achieved satisfactory survival rates and symptom control.