Trial Outcomes & Findings for Portico Valve-in-Valve Retrospective Registry (NCT NCT05002088)

NCT ID: NCT05002088

Last Updated: 2025-02-28

Results Overview

Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications

Recruitment status

COMPLETED

Target enrollment

71 participants

Primary outcome timeframe

30 days post index procedure

Results posted on

2025-02-28

Participant Flow

A total 6 clinical sites from four countries enrolled a total of 71 subjects between October, 2021 and September, 2023. Subjects were enrolled to two cohorts: the Primary Cohort enrolled subjects with a surgical bioprosthesis true inner diameter (ID) between 19 mm and 27 mm, while the Exploratory Cohort enrolled subjects with a true ID outside that range. Once enrolled, subjects completed follow up visits at 30 days, 1-year, and annually through five years.

Participant milestones

Participant milestones
Measure	Primary Analysis Population The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Overall Study STARTED	57	14
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	50	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary Analysis Population The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Overall Study Withdrawal by Subject	9	0
Overall Study Lost to Follow-up	0	1
Overall Study Death	16	2
Overall Study Protocol Violation	25	7

Baseline Characteristics

The age for one subject not available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Total n=71 Participants Total of all reporting groups
Age, Continuous	79.7 years STANDARD_DEVIATION 6.2 • n=56 Participants • The age for one subject not available.	80.6 years STANDARD_DEVIATION 9.3 • n=14 Participants • The age for one subject not available.	79.9 years STANDARD_DEVIATION 0 • n=70 Participants • The age for one subject not available.
Sex: Female, Male Female	16 Participants n=57 Participants	11 Participants n=14 Participants	27 Participants n=71 Participants
Sex: Female, Male Male	41 Participants n=57 Participants	3 Participants n=14 Participants	44 Participants n=71 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=71 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=57 Participants	14 Participants n=14 Participants	71 Participants n=71 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=71 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=71 Participants
Race (NIH/OMB) Asian	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=71 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=71 Participants
Race (NIH/OMB) Black or African American	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=71 Participants
Race (NIH/OMB) White	11 Participants n=57 Participants	8 Participants n=14 Participants	19 Participants n=71 Participants
Race (NIH/OMB) More than one race	0 Participants n=57 Participants	0 Participants n=14 Participants	0 Participants n=71 Participants
Race (NIH/OMB) Unknown or Not Reported	46 Participants n=57 Participants	6 Participants n=14 Participants	52 Participants n=71 Participants
Ejection Fraction	56.1 percent (%) STANDARD_DEVIATION 10.2 • n=57 Participants	59.5 percent (%) STANDARD_DEVIATION 9.9 • n=14 Participants	56.7 percent (%) STANDARD_DEVIATION 0 • n=71 Participants

PRIMARY outcome

Timeframe: 30 days post index procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication.	2 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Composite of all-cause mortality or disabling stroke.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.	7 Participants	0 Participants

SECONDARY outcome

Timeframe: Procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Number of Participants With Procedural Success	53 Participants	12 Participants

SECONDARY outcome

Timeframe: 30 days post index procedure

Population: All values provided have been rounded to the nearest tenth decimal place.

All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular complication, access-related non-vascular complication, or cardiac structure complication, acute kidney injury (AKI) stages 1-4, Endocarditis, Clinically significant valve thrombosis.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Evaluation of Adverse Event Rates (Descriptive Endpoint) Type 1 Bleeding	5.3 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All-cause mortality	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Cardiovascular Mortality	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All stroke	3.5 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Fatal stroke	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke with disability	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke without disability	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) TIA	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Endocarditis	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Clinically significant valve thrombosis	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stage 1 AKI	0.0 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stage 2 AKI	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stage 3 AKI	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stage 4 AKI	0.0 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Type 2 Bleeding	5.3 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Type 3 Bleeding	0.0 percent	21.4 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Type 4 Bleeding	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Major Vascular Complication	1.8 percent	21.4 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Major access-related non-vascular complication	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Major cardiac structure complication	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Myocardial infarction	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Coronary obstruction	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.

All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Endocarditis, Clinically significant valve thrombosis.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Evaluation of Adverse Event Rates (Descriptive Endpoint) All-cause mortality	10.5 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Cardiovascular Mortality	7.1 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All stroke	3.5 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Fatal stroke	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke with disability	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke without disability	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) TIA	1.1 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Endocarditis	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Clinically significant valve thrombosis	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Myocardial infarction	1.9 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Coronary obstruction	4.2 percent	0.0 percent

SECONDARY outcome

Timeframe: 2 years post index procedure

Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.

All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Evaluation of Adverse Event Rates (Descriptive Endpoint) All-cause mortality	12.4 percent	15.6 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Cardiovascular Mortality	9.1 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All stroke	3.5 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Fatal stroke	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke with disability	1.8 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke without disability	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) TIA	1.1 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Endocarditis	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Clinically significant valve thrombosis	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 3 years post index procedure

Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.

All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Evaluation of Adverse Event Rates (Descriptive Endpoint) Endocarditis	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All-cause mortality	24.0 percent	15.6 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Cardiovascular Mortality	13.6 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All stroke	3.5 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Fatal stroke	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke with disability	1.8 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke without disability	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) TIA	1.1 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Clinically significant valve thrombosis	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 4 years post index procedure

Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.

All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke without disability	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All-cause mortality	38.1 percent	15.6 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Cardiovascular Mortality	19.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All stroke	3.5 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Fatal stroke	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke with disability	1.8 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) TIA	1.1 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Endocarditis	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Clinically significant valve thrombosis	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 5 years post index procedure

Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.

All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Evaluation of Adverse Event Rates (Descriptive Endpoint) All-cause mortality	45.8 percent	15.6 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Cardiovascular Mortality	19.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) All stroke	3.5 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Fatal stroke	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke with disability	1.8 percent	7.1 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Stroke without disability	1.8 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) TIA	1.1 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Endocarditis	0.0 percent	0.0 percent
Evaluation of Adverse Event Rates (Descriptive Endpoint) Clinically significant valve thrombosis	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 30 days post index procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=29 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=8 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Assessment of Clinical Benefit Endpoint - NYHA Class Class I	69.0 percent	50.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class II	24.1 percent	37.5 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class III	6.9 percent	12.5 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class IV	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=29 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=8 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Assessment of Clinical Benefit Endpoint - NYHA Class Class IV	0.0 percent	0.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class I	54.5 percent	40.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class II	40.9 percent	40.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class III	4.5 percent	20.0 percent

SECONDARY outcome

Timeframe: 2 years post index procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=21 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=4 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Assessment of Clinical Benefit Endpoint - NYHA Class Class II	28.6 percent	50.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class I	61.9 percent	50.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class III	9.5 percent	0.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class IV	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 3 years post index procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=10 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=3 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Assessment of Clinical Benefit Endpoint - NYHA Class Class I	60.0 percent	66.7 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class II	10.0 percent	0.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class III	30.0 percent	33.3 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class IV	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 4 years post index procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=4 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=1 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Assessment of Clinical Benefit Endpoint - NYHA Class Class I	75.0 percent	100 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class II	0.0 percent	0.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class III	25.0 percent	0.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class IV	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 5 years post index procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=2 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=1 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Assessment of Clinical Benefit Endpoint - NYHA Class Class I	100.0 percent	0.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class II	0.0 percent	0.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class III	0.0 percent	100.0 percent
Assessment of Clinical Benefit Endpoint - NYHA Class Class IV	0.0 percent	0.0 percent

SECONDARY outcome

Timeframe: 30 Days

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Paravalvular Leak as Measured by Core Lab Echocardiography None/trace/trivial	10 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Mild	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Moderate	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 Year

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Paravalvular Leak as Measured by Core Lab Echocardiography None/trace/trivial	5 Participants	2 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Mild	1 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Moderate	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Paravalvular Leak as Measured by Core Lab Echocardiography Moderate	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Severe	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography None/trace/trivial	2 Participants	2 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Mild	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Paravalvular Leak as Measured by Core Lab Echocardiography None/trace/trivial	2 Participants	1 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Mild	1 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Moderate	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Paravalvular Leak as Measured by Core Lab Echocardiography None/trace/trivial	1 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Mild	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Moderate	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=57 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Paravalvular Leak as Measured by Core Lab Echocardiography None/trace/trivial	1 Participants	1 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Mild	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Moderate	0 Participants	0 Participants
Paravalvular Leak as Measured by Core Lab Echocardiography Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=19 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=7 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography	13.90 mmHg Standard Deviation 5.66	14.67 mmHg Standard Deviation 4.82

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=19 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=1 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography	11.13 mmHg Standard Deviation 5.18	8.40 mmHg Standard Deviation 3.58

SECONDARY outcome

Timeframe: 2 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=10 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=3 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography	13.49 mmHg Standard Deviation 6.85	11.17 mmHg Standard Deviation 7.02

SECONDARY outcome

Timeframe: 3 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=5 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=4 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography	12.00 mmHg Standard Deviation 4.78	9.05 mmHg Standard Deviation 4.59

SECONDARY outcome

Timeframe: 4 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=1 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=2 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography	19.90 mmHg Standard Deviation NA Standard Deviation cannot be calculated for one subject. At this time point (4 years), data is only reported for a single subject.	6.50 mmHg Standard Deviation 1.84

SECONDARY outcome

Timeframe: 5 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=2 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=2 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography	9.15 mmHg Standard Deviation 2.19	14.00 mmHg Standard Deviation 10.75

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=15 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=5 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Aortic Valve Area as Measured by Core Lab Echocardiography	1.47 cm^2 Standard Deviation 0.36	1.25 cm^2 Standard Deviation 0.25

SECONDARY outcome

Timeframe: 1 Year

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=13 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=5 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Aortic Valve Area as Measured by Core Lab Echocardiography	1.41 cm^2 Standard Deviation 0.32	1.82 cm^2 Standard Deviation 0.56

SECONDARY outcome

Timeframe: 2 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=7 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=3 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Aortic Valve Area as Measured by Core Lab Echocardiography	1.47 cm^2 Standard Deviation 0.58	1.33 cm^2 Standard Deviation 0.12

SECONDARY outcome

Timeframe: 3 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=3 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=4 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Aortic Valve Area Measured by Core Lab Echocardiography	1.63 cm^2 Standard Deviation 0.20	1.48 cm^2 Standard Deviation 0.37

SECONDARY outcome

Timeframe: 4 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=2 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Aortic Valve Area as Measured by Core Lab Echocardiography	—	1.72 cm^2 Standard Deviation 0.40

SECONDARY outcome

Timeframe: 5 Years

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=1 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=2 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Aortic Valve Area as Measured by Core Lab Echocardiography	2.09 cm^2 Standard Deviation NA Standard deviation cannot be calculated for one subject.	1.26 cm^2 Standard Deviation 0.34

SECONDARY outcome

Timeframe: 30 days

Population: Pacemaker implant (PPI) is unique and only applies to a portion of the patients.

New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=48 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
New Pacemaker Implant	4.2 percent	0.0 percent

SECONDARY outcome

Timeframe: 1 year

Population: Pacemaker implant (PPI) is unique and only applies to a portion of the patients.

New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.

Outcome measures

Outcome measures
Measure	Primary Analysis Population n=48 Participants The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 Participants The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
New Pacemaker Implant	1.8 percent	0.0 percent

Adverse Events

Primary Analysis Population

Serious events: 44 serious events

Other events: 41 other events

Deaths: 16 deaths

Exploratory Registry Arm

Serious events: 10 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Karine Miquel

Abbott

Phone: +32 479 600 107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor will have the right to publish overall study results. Investigators may publish results from their respective participating site per their discretion but only after the multi-center publication is published or 12 months have passed from the study conclusion without a multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Primary Analysis Population n=57 participants at risk The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement	Exploratory Registry Arm n=14 participants at risk The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Blood and lymphatic system disorders Anemia	3.5% 2/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Arrhythmia	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Atrial Fibrillation	3.5% 2/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Atrial Flutter	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Atrioventricular Block Complete	3.5% 2/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Atrioventricular Block Second Degree	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Cardiac Arrest	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Cardiac Failure	3.5% 2/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	14.3% 2/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Cardiac Tamponade	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Cardiomyopathy	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Mitral Valve Incompetence	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Cardiac disorders Myocardial Infarction	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Gastrointestinal disorders Abdominal Pain	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Gastrointestinal disorders Dysphagia	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
General disorders Death	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
General disorders General Physical Health Deterioration	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
General disorders Incarcerated Hernia	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
General disorders Paravalvular Regurgitation	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
General disorders Pyrexia	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Hepatobiliary disorders Hepatic Failure	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Infections and infestations Abscess	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Infections and infestations Covid-19	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Infections and infestations Infection	8.8% 5/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Infections and infestations Pneumonia	3.5% 2/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Infections and infestations Sepsis	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Injury, poisoning and procedural complications Fall	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Injury, poisoning and procedural complications Lower Limb Fracture	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Injury, poisoning and procedural complications Vascular Access Complication	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Injury, poisoning and procedural complications Vascular Access Site Haemorrhage	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	5.3% 3/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Investigations Hemoglobin Decreased	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	14.3% 2/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Metabolism and nutrition disorders Dehydration	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal Carcinoma	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma Multiforme	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Nervous system disorders Cerebrovascular Accident	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Nervous system disorders Cognitive Disorder	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Nervous system disorders Dementia	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Nervous system disorders Peripheral Artery Aneurysm	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Nervous system disorders Peripheral Artery Occlusion	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Nervous system disorders Thrombosis	1.8% 1/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	0.00% 0/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Product Issues Device Dislocation	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	14.3% 2/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Vascular disorders Haemorrhage	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Vascular disorders Hypotension	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
Vascular disorders Iliac Artery Rupture	0.00% 0/57 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.	7.1% 1/14 • 5 years Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.